(387 days)
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end.
All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only.
The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.
The provided document is a 510(k) summary for the "IOM Stimulator Probes" and describes a comparison study against predicate devices to establish substantial equivalence. It does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance or algorithm evaluation (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device has similar technological characteristics to legally marketed predicate devices, and that differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, and training set information, are not applicable to the type of study presented in this document.
Here's an analysis of what is available in the document related to acceptance criteria and the "study" (which is a comparison for substantial equivalence):
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the acceptance criterion for regulatory clearance is establishing substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is demonstrated through a comparison of technological characteristics with predicate devices.
The document provides multiple comparison tables, one for each type of IOM Stimulator Probe. Below is a summarized example for one probe type, to illustrate how the comparison functions as "performance" in this context.
Table: Comparison of IOM Stimulator Probes (Example for Neural stimulator probe insulated monopolar)
| Specification | Acceptance Criteria (Implied by Predicate Performance) | Proposed Spes Medical Probe Performance | Discussion on Equivalence (Meeting Criteria) |
|---|---|---|---|
| Stimulating Surface Area (mm²) | ~4.7 mm² (from Rhythmlink PD) | 7.5 mm² | "The stimulating area is larger than the PD, this doesn't change in dangerous way current densities. So these two differences not affect the safety and effectiveness as compared to the predicate." |
| Tip Diameter (mm) | 0.75 mm (from Rhythmlink PD) | 1.2 mm | "The tip diameter is bigger in Spes Medica device... So these two differences not affect the safety and effectiveness as compared to the predicate." |
| Shaft Length (mm) | 100 mm (from Rhythmlink PD) | 45 mm | "The differences between the two devices are shaft length... Shaft is insulated and the length is only an ease of use... So these two differences not affect the safety and effectiveness as compared to the predicate." |
| Lead Length (cm) | 150 cm and 250 cm (from Rhythmlink PD) | 250 cm | "The cable length is the same 250 cm" |
| Bend Angle (degrees) | 0° (from Rhythmlink PD) | 0° | The bend angle is the same. |
| Material In Contact with Patient | Stainless steel (from PDs) | Stainless steel AISI 316L | Same material. |
| Touch Proof Connector | YES (from PDs) | YES | Same characteristic. |
| Single Use | YES (from PDs) | YES | Same characteristic. |
| Sterilization | EtO (from PDs) | EO sterilized | Same characteristic. |
The document includes similar comparison tables for:
- Neural stimulator probe bipolar hook (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe tripolar hook (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe monopolar ball (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe bipolar balls (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe bipolar concentric (compared to Xian Friendship Medical Electronics)
- Neural stimulator probe bipolar minifork (compared to Medtronic)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The "study" here is a comparison of product specifications and characteristics against predicate devices, not a clinical study involving patients or a performance evaluation against a labeled dataset. There is no "test set" in the context of clinical data or algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. As above, there is no "test set" requiring expert ground truth in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This device is a surgical stimulator probe, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This device is a passive surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The "ground truth" equivalent would be the established specifications and performance of the legally marketed predicate devices, against which the new device's specifications are compared.
8. The sample size for the training set
This information is not applicable and not provided. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
Giorgio Facco Quality Assurance and Regulatory Affairs Spes Medica s.r.1. Via Europa – Zona Industriale Battipaglia (SA), Italy 84091
Re: K133348
Trade/Device Name: IOM Stimulator Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: II Product Code: ETN Dated: October 9, 2014 Received: October 23, 2014
Dear Mr. Facco:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K133348
Device Name IOM Stimulator Probes
Indications for Use (Describe)
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identitY nerves and spinal nerve roots and to assess nerve function. 10M Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the words "spes medica" in a stylized font on the right side. Below the words "spes medica" is the tagline "the medical accessories source" in a smaller font.
510 (k) Summary of safety and effectiveness
SUBMITTER INFORMATION
- A. Company Name:
- B. Company Address:
- C. Company Phone: Company Fax:
- D. Contact Person:
Spes Medica s.r.l. Via Europa - Zona industriale Battipaglia (SA) – Italy 84091 +39 010 39 03 43 +39 010 30 72 345 Giorgio Facco Quality Assurance Spes Medica s.r.l. e-mail: quality@spesmedica.com November 04th 2014
E. Date Summary Prepared:
DEVICE IDENTIFICATION
| A. Device name: | IOM Stimulator Probe |
|---|---|
| B. Trade/Proprietary name: | Stim Probe |
| C. Classification name: | Surgical nerve stimulator/locator (21 CFR §874.1820) |
| D. Product code: | ETN |
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
| Predicate device | Device ClassificationName | 510(k) Applicant | 510(k) number |
|---|---|---|---|
| RHYTHMLINK Monopolarstimulating instrument | Stimulator Nerve | RHYTHMLINKINTERNATIONAL, LLC | K112435 |
| Drytouch Suction Stimulator probe | Stimulator Nerve | NEUROVISION MEDICALPRODUCTS, INC. | K110712 |
| XIAN FRIENDSHIP MEDICAL nervestimulator probes | Stimulator Nerve | XIAN FRIENDSHIPMEDICAL ELECTRONICSCO., LTD. | K112426 |
| SURGICAL STIMULATORS | Stimulator Nerve | TECHNOMED EUROPE | K110422 |
| STIMULUS/DISSECTIONINSTRUMENTS, BALL-TIP PROBES | Stimulator Nerve | MEDTRONIC XOMED,INC | K031003 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows a logo for "spes medica". The logo features a stylized globe on the left side, with the company name "spes medica" written in a cursive font to the right of the globe. Below the company name, there is a tagline that reads "the medical accessories source" in a smaller font. The overall design is simple and professional, suggesting a company that is involved in the medical accessories industry.
DEVICE DESCRIPTION
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end.
All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only.
The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.
INTENDED USE
IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.
{5}------------------------------------------------
IOM Stimulator Probes
SUBSTANTIAL EQUIVALENCE
The IOM Stimulator Probes are similar in interials, packaging and other technological characteristics to the predicate devices.
| Comparison Chart IOM Stimulator Probes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicatedevice | 510(k)Applicant | 510(k)number | Intent for use | TipDiam.mm | ShaftLengthmm* | MaterialIn contactwith patient | Touchproof | Bend Angle | Wire Lengthcm | SingleUse | Steriliz. | Ref.Document |
| RHYTHMLINKMonopolarstimulatinginstrument(LegallyMarketed) | RHYTHMLINKINTERNATIONAL, LLC | K112435 | RhythmlinkInternationalMonopolar-StimulatingInstruments Isindicated forstimulation of cranialand peripheral motornerves for locationand identificationduring surgery;including spinalnerve roots. TheRhythmlinkInternationalMonopolar -StimulatingInstruments is sterileand for single use . | 32.31.60.75StimSurfacemm³ | 100160 | Stainlesssteel | YES | NO | 150250 | YES | EtO | 004_Section 09Rhythmlink |
| DrytouchSuctionStimulatorprobe(LegallyMarketed) | NEUROVISIONMEDICALPRODUCTS,INC. | K110712 | The SuctionStimulator Probe is adedicated manualsurgical instrumentthat allows thesurgeon to clearsecretions and testsurgical tissue withnerve stimulation atthe same time andwith the sameinstrument. It isintended for use onlyby a licensedphysician and inconjunction with theNeurovision SE(Nerveäna) Nervelocator MonitorSystem. | 2StimSurfacemm³8 | 130260 | Stainlesssteel | YES | NO | 150 | YES | EtO | 003_Section 09Neurovision |
| XIANFRIENDSHIPMEDICALnervestimulatorprobes(LegallyMarketed) | XIANFRIENDSHIPMEDICALELECTRONICSCO., LTD. | K112426 | Xian FriendshipDisposable NerveStimulator Probes isused to performlocalized stimulationof neural tissue andto locate, identifyand monitor cranialmotor nerves,peripheral nervesand spinal nerveroots during surgery. | 2.31.30.81.2StimSurfacemm³ | 150÷22080÷15080÷12070÷120 | Stainlesssteel | YES | 90° (doubleHook Probe)100° (doubleand tripleHook Probe)180° (doubleand tripleHook Probe) | Informationnot findable | YES | EtO | 006_Section 09XianFriendshipMedicalElectronics |
| Xian FriendshipDisposable NerveStimulator Probesare sterile (EtO),single-patient-usedevice. | $0.5÷100$ | |||||||||||
| SURGICALSTIMULATORS(LegallyMarketed) | TECHNOMEDEUROPE | K110422 | The TechnomedEurope Kartushdisposable surgicalstimulators areindicated for tissuedissection andstimulation of cranialand peripheral motornerves for locationand identificationduring surgery,including spinalnerve roots. | 0.5StimSurfacemm30.125 | 38,70,100 | Stainlesssteel | YES | NO | Informationnot findable | YES | EtO | 005_Section 09Technomed Europe |
| STIMULUS/DISSECTIONINSTRUMENTS, BALL-TIPPROBES(LegallyMarketed) | MEDTRONICXOMED, INC | K031003 | The Stimulus-DissectionInstruments areindicated for tissuedissection andstimulation of cranialand peripheral motornerves for locationand identificationduring surgery,including spinalnerve roots. | 0.51.312.3StimSurfacemm3$0.125÷12$ | / | Stainlesssteel | YES | NO | Informationnot findable | YES | EtO | 002_Section 09Medtronic |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows a logo for "spes medica the medical accessories source". The logo features a globe on the left side and the company name on the right side. The text is in a stylized font.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows a logo for "spes medica the medical accessories source". The logo features a globe on the left side and the company name on the right side. The globe is a wireframe design, and the company name is written in a cursive font. The text "the medical accessories source" is written in a smaller font below the company name.
IOM Stimulator Probes
*The information about Handle length in not avaible for any models of any predicates device.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the company name "spes medica" on the right side. Below the company name, it says "the medical accessories source" in a smaller font.
IOM Stimulator Probes
IOM Stimulator Probes Comparison
| Spes Medica ProductName and Drawing | Comparison | Spes Medica Description | Predicate device Photo |
|---|---|---|---|
| Neural stimulator probeinsulated monopolarImage: Neural stimulator probe insulated monopolar | The materials is the same,stainless steel, and the probediameter is in the same range:1.2 mm for Spes Medica and1.5 mm for Predicate Device(PD). The shaft length islonger in the PD compared toSpes Medica. The cable lengthis the same 250 cm (PD has150 cm too). Both theproducts as Touch proofconnection . Both productsare sterilized with EtO . | The probe is a monopolar stimulator probe, It is made bystainless steel AISI 316L, It is insulated with termosrhinkabletube with an insulating thickness of 0,25 mm (KBM100). Thepart in contact with the patient is the tip of the probe (AISI316L), the diameter is 1,2 mm and the exposure tip (uncoatedsurface) is 2 mm . The probe length is 45 mm.The body of the probe is made by coloured polystyrene, Itcontains the connection (Tin soldering) between probe andlead wire. After the polystyrene there is blackthermosrhinkable (18 mm) tube to protect the cable. The cableinsulation is made by medical PVC (diameter 1,2 mm). Theconnector is a coloured T.P. DIN 42802 . The device is EOsterilized and for only single use | Image: Standard Monopolar Stimulating ProbeStandard Monopolar Stimulating ProbeRhythmlink |
| Neural stimulator probebipolar hookImage: Neural stimulator probe bipolar hook | The materials is the same,stainless steel, and the probediameter is 1.2 mm for PD and0.65 mm for Spes Medica.The shaft length is longer inthe PD (70÷120mm)compared to Spes Medica (20mm). Both the products asTouch proof connection . Bothproducts are sterilized withEtO . | The probe is a bipolar hook stimulator probe, It is made byStainless steel AISI 304, It is PTFE insulated with insulatingthikness 0,010-0,015 mm (Duraskin). The part in contact withthe patient are the tips of the probe (AISI 304), the diameter is0,65 mm and the exposure tip (uncoated surface) is 6 mm witha radius R 6 mm. The distance between the two probes is 9 mm(center-center). The probes length are 20 mm. The body of theprobe is made by coloured polystyrene, It contains theconnections (Tin soldering) between probes and lead wires.After the polystyrene there is black thermosrhinkable (18 mm)tube to protect the cables. The intertwisted cables insulation ismade by medical PVC (diameter 1,2 mm). The connector is acoloured T.P. DIN 42802 . The device is EO sterilized and foronly single use | Image: Disposable Double Hook Nerve Stimulator Probe-180 degreeDisposable Double Hook Nerve Stimulator Probe-180 degreeXian Friendship Medical Electronics |
| Neural stimulator probetripolar hookImage: Neural stimulator probe tripolar hook | The materials is the same,stainless steel, and the probediameter is 1.2 mm for PD and | The probe is a bipolar hook stimulator probe, It is made byStainless steel AISI 304, It is PTFE insulated with insulatingthikness 0,010-0,015 mm (Duraskin). The part in contact with | Image: Disposable Triple Hook Nerve Stimulator Probe-180 degreeDisposable Triple Hook Nerve Stimulator Probe-180 degree |
| 0.65 mm for Spes Medica.The shaft length is longer inthePD (70÷120mm)compared to Spes Medica (20mm). Both the products asTouch proof connection. Bothproducts are sterilized withEtO. | the patient are the tips of the probe (AISI 304), the diameter is0,65 mm and the exposure tip (uncoated surface) is 6mm witha radius R 6 mm. The distance between the three probes is 4,5mm (center-center each). The probes length are 20 mm. Thebody of the probe is made by coloured polystyrene, It containsthe connections (Tin soldering) between probes and lead wires.After the polystyrene there is black thermoshrinkable (18 mm)tube to protect the cables. The intertwisted cables insulation ismade by medical PVC (diameter 1,2 mm). The connector is acoloured T.P. DIN 42802. The device is EO sterilized and foronly single use | Xian Friendship Medical Electronics | |
| Neural stimulator probemonopolar ball | The materials is the same,stainless steel, and the probediameter is 3 mm for PD and2 mm for Spes Medica. Theshaft length is longer in thePD (100 mm) compared toSpes Medica (30 mm). Thecable length is the same 250cm (PD has 150 cm too). Boththe products as Touch proofconnection. Both productsare sterilized with EtO. | The probe is a monopolar ball stimulator probe, It is made bystainless steel AISI 316L, It is insulated with thermoshrinkabletube with an insulating thickness 0,25 mm (KBM100). The partin contact with the patient is the tip of the probe (AISI 316L),the diameter is 1,7 mm, the ball (exposure tip - uncoatedsurface) has a diameter of 2 mm. The probe length is 30 mm.The body of the probe is made by coloured polystyrene, Itcontains the connection (Tin soldering) between probe and leadwire. After the polystyrene there is blackthermoshrinkable (18 mm) tube to protect the cable. The cableinsulation is made by medical PVC (diameter 1,2 mm). Theconnector is a coloured T.P. DIN 42802.The device is EO sterilized and for only single use | Disposable Ball Tip Direct Nerve Stimulator ProbeXian Friendship Medical Electronics |
| Neural stimulator probemonopolar ball | The materials is the same,stainless steel, and the probediameter is 3 mm for PD and2 mm for Spes Medica. Theshaft length is longer in thePD (100 mm) compared toSpes Medica (45 mm). Thecable length is the same 250cm (PD has 150 cm too). Both | The probe is a monopolar ball stimulator probe, It is made bystainless steel AISI 316L, It is insulated with thermoshrinkabletube with an insulating thickness 0,25 mm (KBM100). The partin contact with the patient is the tip of the probe (AISI 316L),the diameter is 1,7 mm, the ball (exposure tip - uncoatedsurface) has a diameter of 2 mm. The probe length is 45 mm.The body of the probe is made by coloured polystyrene, Itcontains the connection (Tin soldering) between probe and leadwire. After the polystyrene there is blackthermoshrinkable | Disposable Ball Tip Direct Nerve Stimulator Probe |
| the products as Touch proofconnection . Both productsare sterilized with EtO . | thermosrhinkable (18 mm) tube to protect the cable. The cableinsulation is made by medical PVC (diameter 1,2 mm). Theconnector is a coloured T.P. DIN 42802 . The device is EOsterilized and for only single use | ||
| Neural stimulator probebipolar ballsImage: [Neural stimulator probe bipolar balls] | The materials is the same,stainless steel, and the probediameter is the same for PDand Spes Medica (2 mm). Theshaft length is longer in thePD ( $70\div120$ mm) compared toSpes Medica (30 mm).Both the products as Touchproof connection . Bothproducts are sterilized withEtO . | The probe is a bipolar balls stimulator probe, It is made bystainless steel AISI 316L, It is insulated with termosrhinkabletube with an insulating thickness 0,25 mm (KBM100). The partin contact with the patient is the tip of the probe (AISI 316L),the diameter is 1,7 mm, the balls (exposure tips - uncoatedsurfaces) have a diameter of 2 mm . The distance between thetwo probes is 6,5 mm (center-center). The probe length is 30mm.The body of the probe is made by coloured polystyrene, Itcontains the connection (Tin soldering) between probe andlead wire. After the polystyrene there is blackthermosrhinkable (18 mm) tube to protect the cables. Thecable insulation is made by medical PVC (diameter 1,2 mm).The connector is a coloured T.P. DIN 42802 .The device is EO sterilized and for only single use | Image: [Disposable Double Ball Tip Direct Nerve Stimulator Probe]Xian Friendship Medical Electronics |
| Neural stimulator probebipolar concentricImage: [Neural stimulator probe bipolar concentric] | The materials is the same,stainless steel, and the probediameter is 0.8 mm for PD and0.32 mm for Spes MedicaThe shaft length is longer inthe PD ( $80\div150$ mm)compared to Spes Medica (45 | The probe is a bipolar concentric stimulator probe, It is madeby stainless steel AISI 304 canula with internal sensor instainless steel AISI 304, It is insulated with PTFE with aninsulating thickness 0,010-0,015 mm (Duraskin). The part incontact with the patient is AISI 304, the diameter of canula is1,5 mm, the sensor tip has a diameter of 0,32 mm and alength of 0.3 mm. The probe length is 45mm. | Image: [Disposable Concentric Direct Nerve Stimulator Probe]Xian Friendship Medical Electronics |
| mm).Both the products as Touchproof connection . Bothproducts are sterilized withEtO . | The body of the probe is made by coloured polystyrene, Itcontains the connection (Tin soldering) between probe andlead wire. After the polystyrene there is blackthermosrhinkable (18 mm) tube to protect the cables. Thecable insulation is made by medical PVC (diameter 1,2 mm).The connector is a coloured T.P. DIN 42802.The device is EO sterilized and for only single use | Image: Xian Friendship Medical Electronics | |
| Xian Friendship Medical Electronics | |||
| Image: Neural stimulator probe bipolar minifork | The materials is the same,stainless steel, and the probediameter is 1.3 mm for PD and0.65 mm for Spes Medica.Both the products as Touchproof connection . Bothproducts are sterilized withEtO . | The probe is a bipolar minifork stimulator probe, It is made bystainless steel AISI 304, It is insulated with PTFE with aninsulating thickness0,010-0,015 mm (Duraskin). The diameterare 0,65 mm, the exposure tips (uncoated surface) have alength of 2 mm . The distance between the two probes is 1,5mm (center-center). The probe length is 30 mm.The body of the probe is made by coloured polystyrene, Itcontains the connection (Tin soldering) between probe andlead wire. After the polystyrene there is blackthermosrhinkable (18 mm) tube to protect the cables. Thecable insulation is made by medical PVC (diameter 1,2 mm).The connector is a coloured T.P. DIN 42802The device is EO sterilized and for only single use | Image: Kartush Side-by-Side Bipolar Stimulator ProbeMedtronic |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows a logo for "spes medica, the medical accessories source". The logo includes a stylized globe on the left side. The text is in a serif font and is slightly stylized.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the words "spes medica" on the right side. Below the words is the phrase "the medical accessories source" in a smaller font.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Spes Medica. The logo consists of a globe on the left and the words "spes medica" on the right. Below the words is the phrase "the medical accessories source".
{12}------------------------------------------------
Image /page/12/Picture/2 description: The image shows a logo for "spes medica". The logo features a globe on the left side and the company name on the right side. Below the company name is the text "the medical accessories source".
| Neural stimulator probe insulated monopolar | ||
|---|---|---|
| Specification | Proposed Spes Medical Probe | Rhythmlink – Standard MonopolarStimulating Probe |
| Stimulating Surface Area (mm2) | 7.5 mm² | 4.7 mm² |
| Tip Diameter (mm) | 1.2 mm | 0.75 mm |
| Shaft Length (mm) | 45 mm | 100 mm |
| Lead Length (mm) | 250 cm | 250 cm and 150 cm |
| Bend Angle (degrees) | 0° | 0° |
| Discussion | The differences between the two devices are shaft length and tip diameter.Shaft is insulated and the length is only an ease of use. The tip diameter isbigger in Spes Medica device, the stimulating area is larger than the PD,this doesn't change in dangerous way current densities. So these twodifferences not affect the safety and effectiveness as compared to thepredicate. |
| Neural stimulator probe bipolar hook | ||
|---|---|---|
| Specification | Proposed Spes Medical Probe | Xian Friendship Medical Electronics –Disposable Double Hook NerveStimulator Probe |
| Stimulating Surface Area (mm2) | 30.6 mm2 | 37.7 mm2 |
| Tip Diameter (mm) | 0.65 mm | 1.2 mm |
| Shaft Length (mm) | 20 mm | 70-120 mm |
| Lead Length (mm) | 250 cm | Information not available |
| Bend Angle (degrees) | 180° | 180° |
| Discussion | The differences between the two devices are shaft length and tip diameter.Shaft is insulated and the length is only an ease of use. The tip diameter isbigger in PD, but the stimulating area doesn't change in dangerous waycurrent densities. So these two differences not affect the safety andeffectiveness as compared to the predicate. |
| Neural stimulator probe tripolar hook | ||
|---|---|---|
| Specification | Proposed Spes Medical Probe | Xian Friendship Medical Electronics –Disposable Triple Hook NerveStimulator Probe |
| Stimulating Surface Area (mm²) | 30.6 mm² | 37.7 mm² |
| Tip Diameter (mm) | 0.65 mm | 1.2 mm |
| Shaft Length (mm) | 20 mm | 70-120 mm |
| Lead Length (mm) | 250 cm | Information not avaible |
| Bend Angle (degrees) | 180° | 180° |
| Discussion | The differences between the two devices are shaft length and tip diameter.Shaft is insulated and the length has only an ease of use. The tip diameter isbigger in PD device, stimulating area is smaller than the PD, but thestimulating area doesn't change in dangerous way current densities.So these two differences not affect the safety and effectiveness ascompared to the predicate. |
{13}------------------------------------------------
Image /page/13/Picture/2 description: The image shows the logo for "spes medica". The logo consists of a globe on the left and the company name on the right. Below the company name is the tagline "the medical accessories source".
| Neural stimulator probe monopolar ball | ||
|---|---|---|
| Specification | Proposed Spes Medical Probe | Xian Friendship Medical Electronics -Disposable Ball Tip Direct NerveStimulator Probe |
| Stimulating Surface Area (mm2) | 50.2 mm2 | 66 mm2 |
| Tip Diameter (mm) | 2 mm | 2.3 mm |
| Shaft Length (mm) | 30 mm and 45 mm | 70-150 mm |
| Lead Length (mm) | 250 cm | Information not available |
| Bend Angle (degrees) | 0° | 0° |
| Discussion | The differences between the two devices are shaft length and tip diameter.Shaft is insulated and the length has only an ease of use. The tip diameter isbigger in Spes Medica device stimulating area is smaller than the PD, butthe stimulating area doesn't change in dangerous way current densities.So these two differences not affect the safety and effectiveness ascompared to the predicate |
| Neural stimulator probe bipolar balls | ||
|---|---|---|
| Specification | Proposed Spes Medical Probe | Xian Friendship Medical Electronics –Disposable Double Ball Tip DirectNerve Stimulator Probe |
| Stimulating Surface Area (mm²) | 51 mm² | 51 mm² |
| Tip Diameter (mm) | 2 mm | 2 mm |
| Shaft Length (mm) | 30 mm | 70-150 mm |
| Lead Length (mm) | 250 cm | Information not available |
| Bend Angle (degrees) | 0° | 0° |
| Neural stimulator probe bipolar concentric | ||
|---|---|---|
| Specification | Proposed Spes Medical Probe | Xian Friendship Medical Electronics –Disposable Concentric Direct NerveStimulator Probe |
| Stimulating Surface Area (mm²) | 211 mm² | 201-377 mm² |
| Tip Diameter (mm) | 1.5 mm | 0.8 mm |
| Shaft Length (mm) | 45 mm | 80-150 mm |
| Lead Length (mm) | 250 mm | Information not available |
| Bend Angle (degrees) | 0° | 0° |
| Discussion | The differences between the two devices are shaft length and tip diameter.Shaft is insulated and the length has only an ease of use. The tip diameter isbigger in Spes Medica device and shaft length is bigger in the PD. At theend the Spes Medica stimulating area is in the range of the PD stimulatingarea. So these two differences not affect the safety and effectiveness ascompared to the predicate. |
| Neural stimulator probe bipolar minifork |
|---|
| ------------------------------------------ |
| Specification | Proposed Spes Medical Probe |
|---|---|
| Medtronic – Kartush Side-by-Side |
{14}------------------------------------------------
Image /page/14/Picture/2 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the company name "spes medica" on the right side. Below the company name, it says "the medical accessories source" in a smaller font.
| Bipolar Stimulator Probe | ||
|---|---|---|
| Stimulating Surface Area (mm2) | 9.4 mm2 | 8 mm2 |
| Tip Diameter (mm) | 1.5 mm | 1.3 mm |
| Shaft Length (mm) | 45 mm | Information not avaible |
| Lead Length (mm) | 250 mm | Information not avaible |
| Bend Angle (degrees) | 0° | 0° |
| Discussion | The differences between the two devices is the tip diameter that is bigger in Spes Medica device. At the end the stimulating area for the two devices is larger than the PD, this doesn't change in dangerous way the current. So this difference not affect the safety and effectiveness as compared to the predicate. |
| Nonclinical testing performed |
|---|
| Biocompatibility |
| Ethylene Oxide Sterilization |
| Dielectric strength |
| Packaging |
| Cleaning Room |
CONCLUSION
Comparing these tables and each Spes Medica IOM Stimulator Probes models with PD models we can say that the safety and effectiveness of our device as compared to legally marketed predicate devices. The conclusion of Spes Medica s.r.l. is that the IOM Stimulator Probes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.