(101 days)
The Technomed Europe Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Kartush Disposable surgical stimulators are invasive devices used in the tissue dissection and monopolar stimulating. The instruments have different tip shapes for performing different dissection and stimulating procedures. The tip, tapered shaft, handle and connection pin are made of 1 pieces material. The instruments are designed for single-patient/multiple application use. The detachable lead wire has a safety DIN 42802 connector.
This document describes the premarket notification (510(k)) for Technomed Europe's Kartush Disposable Surgical Stimulators. It does not contain information about a study proving the device meets acceptance criteria in the way you've outlined for performance studies (e.g., diagnostic accuracy with medical imaging or other AI/software as a medical device).
Instead, this 510(k) submission establishes substantial equivalence to a predicate device (Medtronic Xomed Stimulus/Dissection Instruments, Ball-Tip Probes, K031003) for regulatory clearance. The "acceptance criteria" here are based on the comparison of characteristics between the proposed device and the predicate.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the proposed device demonstrates characteristics that are "same as" or "equivalent to" the predicate device, especially regarding safety and effectiveness.
| Characteristic | Acceptance Criteria (Predicate Device K031003) | Reported Device Performance (Kartush Disposable Surgical Stimulators) |
|---|---|---|
| Indications for Use | Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery including spinal nerve roots. | Same |
| Base material | Stainless steel | Same |
| Electrical insulation | Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection | Same |
| Distal patient contact surface material | Stainless steel | Same |
| Proximal stimulator connector | Yes | Yes |
| IEC 60601-1 protected pin design | Touch proof connector | Same |
| Patient contact material | Biocompatible | Same |
| Use and delivery | Single use and sterile | Same |
| Non-clinical data | Performance characteristics of predicate device. | Bench testing confirmed equivalence in: - Dimensional measurements (current density)- Impedance tests (through saline)- Material comparison- Dielectric strength test (shaft and handle insulation) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the context of a clinical study or a labeled "test set" for performance evaluation against a ground truth. The evaluation was based on a comparison of device specifications and the results of bench testing for the proposed devices against the characteristics of the predicate device.
- Data Provenance: The bench testing was conducted by Technomed Europe (manufacturer located in The Netherlands). The document does not specify if external labs were used or the specific origin of materials, but the testing was conducted by the manufacturer.
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)
Not applicable. This is not a study requiring expert consensus for ground truth on clinical data. The "ground truth" for this 510(k) is the established performance and safety profile of the predicate device, as already cleared by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical study involving human readers or cases requiring 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 device is a surgical instrument (nerve stimulator/locator), not an AI-powered diagnostic tool. Thus, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this substantial equivalence submission is based on the previously FDA-cleared predicate device's design specifications, materials, and established indications for use and safety/effectiveness profile, as demonstrated through non-clinical (bench) testing. The non-clinical data (bench testing) performed on the proposed device aimed to confirm that its performance characteristics (e.g., current density, impedance, insulation integrity) were equivalent to those expected from the predicate.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for an AI/machine learning model. The basis of comparison is the predicate device's established regulatory clearance and characteristics.
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| 510(k) Summary | |
|---|---|
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands |
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888 |
| Contact person: | Mr. Pierre VreulsManager Regulatory Affairs and Quality AssuranceE-mail: pvreuls@technomed.nl |
| Date: | February 11, 2011 |
| Proprietary Name: | Kartush Disposable Surgical stimulators |
| Common/usual Name: | Surgical nerve stimulator/locator |
| Classification Name: | Surgical nerve stimulator/locator is classified as class II per 21CFR section 874.1820. Product code ETN. |
| Substantial Equivalence: | K031003: Medtronic Xomed Stimulus/Dissection Instruments,Ball-Tip Probes |
| Device description: | Kartush Disposable surgical stimulators are invasive devices usedin the tissue dissection and monopolar stimulating. Theinstruments have different tip shapes for performing differentdissection and stimulating procedures. The tip, tapered shaft,handle and connection pin are made of 1 pieces material. Theinstruments are designed for single-patient/multiple applicationuse.The detachable lead wire has a safety DIN 42802 connector. |
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K110422 p.2 of 3
Name and model numbers new devices:
| Predicate device MedtronicXomed [K031003] | Technomed Europe surgicalstimulators[proposed device] | New model numbers[proposed device] |
|---|---|---|
| Medtronic Xomed name | Proposed device name | Internal model # |
| KSD Curved needle | Kartush Curved needle | 42301-001 |
| KSD Elevator | Kartush Elevator | 42302-001 |
| KSD Ring dissector, 3mm thin | Kartush Ring dissector, 3mm thin | 42303-001 |
| KSD Ring dissector, 2mm thin | Kartush Ring dissector, 2mm thin | 42303-002 |
| KSD Sickle knife | Kartush Sickle knife | 42304-001 |
| KSD 90° hook | Kartush 90° hook | 42305-001 |
| KSD Crabtree | Kartush Crabtree | 42306-001 |
| KSD Ring dissector, 3mm reg. | Kartush Ring dissector, 3mm reg. | 42303-003 |
| KSD Ring dissector, 2mm reg. | Kartush Ring dissector, 2mm reg. | 42303-004 |
Extension cable to connect device to appropriate equipment:
| Predicate device Medtronic | Technomed Europe surgical | New model numbers |
|---|---|---|
| Xomed [K031003] | stimulators[proposed device] | [proposed device] |
| Medtronic Xomed name | Proposed device name | Internal model # |
| KSD connection lead wire | Kartush 3m extension cable DIN42802 to DIN 42802 | 42307-001 |
Needle electrode already released under 510(k) K990015 (no predicate needed):
| Description | Device Name | Internal model # |
|---|---|---|
| Needle electrode | Disposable subdermal needle electrode | 40072-001 |
Commercial sets planned with above products:
| New catalog numbers set | Technomed Europe surgicalstimulators | New model numbers |
|---|---|---|
| Proposed catalog # set | Proposed device name | Internal model # |
| 4007-00-KT | Kartush Curved needle | 42301-001 |
| Kartush Elevator | 42302-001 | |
| Kartush Ring dissector, 3mm thin | 42303-001 | |
| Kartush 3m extension cable DIN42802 to DIN 42802 | 42307-001 | |
| Disposable subdermal needleelectrode | 40072-001 | |
| Kartush Ring dissector, 2mm thin | 42303-002 | |
| Kartush Sickle knife | 42304-001 | |
| Kartush 90° hook | 42305-001 | |
| Kartush Crabtree | 42306-001 | |
| 4009-00-KT | Kartush Ring dissector, 3mm reg. | 42303-003 |
| Kartush Ring dissector, 2mm reg. | 42303-004 | |
| Kartush 3m extension cable DIN42802 to DIN 42802 | 42307-001 | |
| Disposable subdermal needleelectrode | 40072-001 |
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110422 p.3 of 3
| Intended Use: | The Technomed Europe Kartush disposable surgical stimulatorsare indicated for tissue dissection and stimulation of cranial andperipheral motor nerves for location and identification duringsurgery, including spinal nerve roots. |
|---|---|
| Comparison to predicates: | The design, materials, chemical composition, packaging andother technological characteristics of the subject device isequivalent to those of the predicate devices. |
| Non-clinical data: | Technomed Europe has been bench testing the Kartushdisposable surgical stimulators to confirm performancecharacteristics of this device. The bench testing consisted ofdimensional measurements to determine the current density,impedance tests of the tips of the devices through saline, materialcomparison and dielectric strength test of the shaft and handleinsulation. The conclusion of these bench tests is that the subjectdevices are equivalent to the predicate devices. |
| Comparison of characteristics between Kartush disposable surgical stimulators and the predicate |
|---|
| device: |
| Characteristic | Predicate device Medtronic Xomed[K031003] | Technomed Europe's Kartushdisposable surgicalstimulators [proposed device] |
|---|---|---|
| Indications for use | Tissue dissection and stimulation of cranialand peripheral motor nerves for location andidentification during surgery including spinalnerve roots. | Same |
| Base material | Stainless steel | Same |
| Electrical insulation | Electrical insulation on all surfaces notintended to provide electrical contact with thepatient and connection | Same |
| Distal patient contactsurface material | Stainless steel | Same |
| Proximal stimulatorconnector | Yes | Yes |
| IEC 60601-1protected pin design | Touch proof connector | Same |
| Patient contactmaterial | Biocompatible | Same |
| Use and delivery | Single use and sterile | Same |
Conclusion:
The comparison to the predicate devices demonstrate that the Kartush disposable surgical stimulators are safe and effective and are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 6 2011
Technomed Europe c/o Pierre Vreuls Manager Regulatory Affairs Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
Re: K110422
Trade/Device Name: Kartush Disposable Surgical Stimulators Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: April 18, 2011 Received: April 21, 2011
Dear Mr. Vreuls:
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, listing 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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Signature
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K110422
Kartush disposable surgical stimulators Device Name:
Indications For Use:
The Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
John Doucet
John Doucet
Page 1 of 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110422
§ 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.