(63 days)
Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use for Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals in example and they are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The Subdermal Needle Electrodes are used for recording and stimulation (micro stimulation), this stimulation has no therapeutic purpose but has the purpose of activating an electrical response.
The provided text describes the acceptance criteria and performance testing of the Spes Medica Subdermal Needle Electrodes, but it largely focuses on biocompatibility, sterilization/packaging, and electrical safety standards rather than a comparative effectiveness study involving human readers or AI.
Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale clinical data will not be present in this document.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Description/Standard) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5) | No reactivity |
| Skin Irritation (ISO 10993-10) | Negligible irritation response |
| Hemolysis test (ISO 10993-4) | Does not cause hemolysis |
| Skin Sensitization (ISO 10993-10) | Not sensitizing |
| Systemic Toxicity (ISO 10993-11) | No toxic symptoms, satisfies requirements |
| Pyrogenicity test (ISO 10993-11) | Meets requirements for absence of pyrogens |
| Sterilization/Packaging | |
| Packaging Validation Protocol (5 years shelf-life) | No substantial alterations after aging process, devices remain sterile (Tested against ASTM D4332, ASTM D4169, ISO 11135-1, 11737-1, 11737-2) |
| Packaging validation test (Sterility test) | All samples met seal strength requirements per ASTM F88 |
| Electrical Safety | |
| Electrical Safety - Isolation (IEC 60601-1: 3rd Ed + CORR 2:2007 + A1:2012 clause 8.5.2.3) | Isolated and in compliance with requirements for electrically safety |
| Impedance test and dielectric strength | Stimulation doesn't affect or reduce the needle and its performance |
| Physical Performance | |
| Cable tensile testing | Very high strength force (average 40.1 N) during pull-out test, ensuring manufacturing process safety and strength of use |
| Shipment Tests (Handling, Vehicle Stacking, Loose Load Vibration, Vehicle Vibration, Concentrated Impact) | No damage to the product observed |
| Climatic Tests (Changing temperature and relative humidity) | No damage to the product observed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "test sets" or data provenance in the way one would for an AI or clinical study. The performance tests are laboratory-based and conducted on the device components or prototypes. The sample sizes for each specific test (e.g., number of units tested for tensile strength, number of samples for biocompatibility) are not explicitly stated, nor is the country of origin or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes performance testing for a medical device to establish its safety and effectiveness based on international standards, not the establishment of ground truth by clinical experts for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic study requiring expert adjudication.
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
Not applicable. This document does not describe an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various performance tests, the "ground truth" is defined by the requirements of the international standards (e.g., ISO, ASTM, IEC) that the device must meet. For biocompatibility tests, it's the biological response against established thresholds; for electrical safety, it's adherence to voltage and isolation limits; for mechanical tests, it's resistance to forces.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Spes Medica S.r.l. Giorgio Facco Regulatory Affairs & Quality Assurance Via Europa - Zona Industriale Battipaglia (SA), 84091 Italy
Re: K192603
Trade/Device Name: Spes Medica Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: September 18, 2019 Received: September 20, 2019
Dear Giorgio 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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
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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192603
Device Name
Spes Medica Subdermal Needle Electrodes
Indications for Use (Describe)
Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
| 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) |
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510(k) Summary
| Manufacturer's Name: | Spes Medica S.r.l.via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|---|---|
| Official Correspondent: | Giorgio FaccoQuality Assurance and Regulatory Affairs |
| Telephone Number: | 0039 0828 614191 |
| Fax Number: | 0039 0828 341788 |
| Trade Names: | Spes Medica Subdermal Needle Electrodes |
| Common or Usual Name: | Subdermal Needle Electrodes |
| Classification Name: | Needle electrode |
| Device Class: | Class II |
| Product Code: | GXZ |
| Classification Regulation: | 882.1350 |
| Predicate Device: | Rhythmlink International Subdermal Needle Electrodes (K022914) |
| Device Description: | Spes Medica Subdermal Needle Electrodes are monopolar needles intented to usefor Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentialsignals in example and they are intended for use with recording, monitoring andstimulation equipment for the purpose of recording of biopotential signals. TheSubdermal Needle Electrodes are used for recording and stimulation (microstimulation), this stimulation has no therapeutic purpose but has the purpose ofactivating an electrical response. |
| Intended Use: | Spes Medica Subdermal Needle Electrodes are intended for use with recording,monitoring and stimulation equipment for the purpose of recording of biopotentialsignals. Examples include: Electromyography (EMG), Electroencephalograph (EEG) andNerve potential signals. The electrodes are sterile and for single patient use only. |
| Technological Comparison: | The electrodes consist of stainless steel needle with a lead wire attached. The leadwires terminate in a safety connector that cannot be connected to an AC poweroutlet. The characteristics of Spes Medica Subdermal Needle Electrodes aresubstantially equivalent to the predicate devices. No new questions of safety oreffectiveness are raised, Spes Medica Subdermal Needle Electrodes employ thesame technological characteristics as the predicate device. |
| Substantial Equivalence: | Spes Medica Subdermal Needle Electrodes are equivalent to the device clearedunder K022914 as is presented below in Table. |
lt has been shown in this 510(k) submission that the differences between the Spes Medica Subdermal Needle Electrodes and the predicate device Rhythmlink International Needle Electrodes do not raise any questions regarding its safety and effectiveness. The Spes Medica Subdermal Needle is substantially equivalent to the predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices. The Spes Medica Subdermal Needle Electrodes, as designed and manufactured to be substantially equivalent to the referenced predicate devices.
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| Manufacturer | Rhythmlink International LLC | Spes Medica S.r.l. | |
|---|---|---|---|
| Trade Name | Rhythmlink International Subdermal Needle Electrodes | Spes Medica Subdermal Needle Electrodes | |
| 510(k) number | K022914 | K192603 | Discussion Differences |
| Product Code | GXZ | GXZ | |
| Intent for use | Rhythmlink International Subdermal Needle Electrodesare intended for use with recording, monitoring andstimulation equipment for the purpose of recording ofbiopotentialsignals.Examplesinclude:Electromyography (EMG), Electroencephagraph (EEG)and Nerve potential signals. The electrodes are sterileand for single patient use only. | Spes Medica Subdermal Needle Electrodes areintended for use with recording, monitoring andstimulation equipment for the purpose of recordingbiopotentialsignals.Examplesinclude:otElectromyographyElectroencephagraph(EMG),(EEG) and Nerve potential signals. The electrodes aresterile and for single patient use only. | The same of the predicate device |
| Regulation Name | Needle electrode | Needle electrode | The same of the predicate device |
| Regulation Number | 882.1350 | 882.1350 | The same of the predicate device |
| Direction for the use | Select appropriate Subdermal Needle Electrode. Whenintroducing Electrode into patient, do not insert up tohub. If needle bends before, during or after insertion, donot straighten or re-insert. Discard and replace with anew Electrode. CAUTION: Needles are sterile only ifpackaging is unopened.Cleaning & Disinfecting Instructions - This product issingle-patient use only. Discard Electrode after use.Other Needle Varieties - Parallel Pairs, Bent andCorkscrew | (1)Do not use the selected needle if the pouch isdamaged;(2)Open the pouch and remove needle from sterilepouch;(3)Connect the needle with the equipment;(4)Remove the needle sheath;(5)Introduce the needle into the area to be tested. Insertthe needle up to hub.(6)After the use, dispose the needle according tostandard protocols or alternatively put the needle inapprove biohazard sharps containers.The electrodes are sterile and for single patient only.Other Needle Varieties - Parallel Pairs, Bent andCorkscrew | No significant difference. |
| Hub Diameter | 1.25 mm | 1.25 mm | The same of the predicate device |
| Needle Length | 7, 13, 19 and 22 mm | 7÷22 mm | The same of the predicate device |
| Needle Diameter | 0.4 mm, 0.6 mm | 0.4 mm, 0.6 mm | The same of the predicate device |
| Connector | DIN 42802 | DIN 42802 | The same of the predicate device |
| Leadwire Lengths | 1.0, 1.5 and 2.5 m | 1.0, 1.5 and 2.5 m | The same of the predicate device |
| Needle | Stainless Steel | Stainless Steel | The same of the predicate device |
| Needle Hub | Polyvinylidene Flouride- Polyethelyne (for cork screw) | Polyvinylidene Flouride- Polyethelyne (for cork screw) | The same of the predicate device |
| Leadwire | Tinned Copper with PVC Jacket Connector | Tinned Copper with PVC Jacket Connector | The same of the predicate device |
| Protective Cover | PVC, Radio-Opaque Blue | PVC, Radio-Opaque Blue | The same of the predicate device |
| Single Use | Yes | Yes | The same of the predicate device |
| Provided to the usersterile | Yes | Yes | The same of the predicate device |
| Sterilization | Ethylene Oxide | Ethylene Oxide | The same of the predicate device |
| Manufacturer | Rhythmlink International LLC | Spes Medica S.r.l. | |
| Trade Name | Rhythmlink International Subdermal Needle Electrodes | Spes Medica Subdermal Needle Electrodes | Discussion Differences |
| 510(k) number | K022914 | K192603 | |
| Product Code | GXZ | GXZ | |
| Shelf life | - | 5 years | - |
| Single Use | Yes | Yes | The same of the predicate device |
| Pouch(Transparent Layer) | Polyethylene | Polyethylene | The same of the predicate device |
| Pouch | Tyvek | Medical Paper | No significant difference. Bothmaterials are validated. |
| Pouch Size | 70 x 160 mm | 75X200 mm | No significant difference |
| Box | Paperboard | Paperboard | The same of the predicate device |
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| Performance Testing Summary | ||
|---|---|---|
| Test | Description | Results |
| Cytotoxicity | These methods are designed to determine the biological response ofmammalian cells in vitro using appropriate biological parameters. | The test material showed no reactivity |
| Skin Irritation | This method describes the procedure for the assessment of medicaldevices and their constituent materials with regard to their potential toproduce irritation and skin sensitization. | The test material showed a negligible irritation response. |
| Haemolysis test | The aim of the present report is to describe procedure and results obtainedfor haemolytical potential evaluation test (haemolysis test) of medicaldevice in object. | Subdermal Needles manufactured by purchaser SPES MEDICA doesnot cause haemolysis. |
| Skin sensitization | This method describes the procedure for the assessment of medicaldevices and their constituent materials with regard to their potential toproduce irritation and skin sensitization. | On the basis of the results the tested item must be considered notsensitizing. |
| Systemic toxicity | This method is a biological evaluation to evaluate the systemic toxicity. | On the basis of the results the tested item doesn't cause toxicsymptoms and satisfies the requirements of the test. |
| Pyrogenicity test | The aim of the present report is to describe procedure and results obtainedfor Pyrogen Test. | On the basis of the results the tested item meets the requirementfor the absence of pyrogens |
| Packaging ValidationProtocol(5 years of shelflife) | The accelerated aging process describes a procedures for developingaccelerated aging protocols to rapidly determine the effects, if any, due tothe passage of time on sterile integrity of the sterile barrier system. | The results stated that the devices and the relative packaging haveno substantial alterations after aging processthe devices results sterile. |
| Performance Testing Summary | ||
| Test | Description | Results |
| Packaging validation test(Sterility test) | The test is performed in order to determine the charge (expressed in$Newton/cm^2$ ) necessary to separate the two sides of the seal. This test isperformed on both dry and wet material. | All samples met seal strength requirements per ASTM F88 |
| Cable tensile testing | Spes Medica have been tested to get a feedback on the tensile strength ofsubdermal needles and to understand the limit value during pull out thecable. | The results obtained show that for Spes Medica subdermalneedles have a very hight strength force during the pull-out test.The average is 40.1 N and this value doesn't affect the needle orthe connection part but it is the limit of the cables. The results giveto Spes Medica subdermal needles the safety of manufacturingprocess and the strength of the use. |
| Impedance test anddieletrich strength | Spes Medica have been tested to get a feedback on the subdermal needlesuse not only for recording but also for stimulation. The aim is to confirmthat the devices do not lose their features or worsen their performancesafter stimulation. | The results obtained show that for Spes Medica subdermalneedles, stimulation doesn't affect or reduce the needle and itsperformance |
| Electrically Safety -Isolation | Evaluate the isolation of the product in the different part at differentvoltage 250V, 500V and 1000V. | The results obtained show that for Spes Medica subdermalneedles are isolated and are in compliance with requirements forelectrically safety. |
| Shipment Tests | Understand if:• HANDLING TEST,• VEHICLE STACKING TEST,• LOOSE LOAD VIBRATION TEST,• VEHICLE VIBRATION TEST,• CONCENTRATED IMPACT TESThave a impact on packaging and materials | No damage of the product has been observed |
| Climatic Tests | Understand if changing temperature and relative humidity (RH) haveeffects on packaging and materials which may be related to their fieldperformance. | No damage of the product has been observed |
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We specify that the test articles used in the Performance Testing Summary table are incined, sterlized proposed in the 510() submission per formulation, suppliers, processing, packaging (including dose and duration), and geometry and no chemicals have been added (eg, plasticies, fillers, color additives, cleaning agents, mold release agents).
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Performance testing - conformance to international standards
The Spes Medica Subdermal Needle Electrodes demonstrated conformance to the following applicable international standards:
- Biocompatibility: ISO 10993-4, 10993-5, 10993-10, and 10993-11
- Sterilization/packaging: ISO 11135-1, 11737-1, and 11737-2; ASTM D4332, ASTM D4169
- Electrical safety:IEC 60601-1: 3rd Ed + CORR 2:2007 + A1:2012 clause 8.5.2.3
Conclusion
All performance testing conducted as outlined above demonstrate that the performance and design specifications. Based on the results obtained, Spes Medica Subderma Needle Electrodes are substantially equivalent and performs as well as the the predicate devices (K022914).
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).