(101 days)
No
The summary describes a simple electrical stimulator for nerve identification during surgery and does not mention any AI or ML components or functionalities.
Yes
The device is used to stimulate nerves to locate and identify them during surgery. While this is a diagnostic aid during surgery, nerve stimulation can also have a therapeutic effect. The intended use for this device is "tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery". Stimulation can be a therapeutic intervention.
No
The device is described as a surgical stimulator indicated for tissue dissection and stimulation of nerves for location and identification during surgery. Its function is to stimulate nerves, not to diagnose a medical condition or disease.
No
The device description clearly states it is an invasive device with physical components (tip, shaft, handle, connection pin, lead wire) made of material, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery". This is a direct surgical intervention on the patient's body.
- Device Description: The description confirms it's an "invasive device used in the tissue dissection and monopolar stimulating". This further reinforces its use in direct surgical procedures.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.
The device is a surgical instrument used during surgery on the patient, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial and peripheral motor nerves, spinal nerve roots.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technomed Europe has been bench testing the Kartush disposable surgical stimulators to confirm performance characteristics of this device. The bench testing consisted of dimensional measurements to determine the current density, impedance tests of the tips of the devices through saline, material comparison and dielectric strength test of the shaft and handle insulation. The conclusion of these bench tests is that the subject devices are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
p.10 + 3 K110422
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:・・・
| 510(k) Summary | |
|---|---|
| Manufacturer: | Technomed Europe |
| Amerikalaan 71 | |
| 6199 AE Maastricht Airport | |
| The Netherlands | |
| Submitted by: | Technomed Europe |
| Amerikalaan 71 | |
| 6199 AE Maastricht Airport | |
| The Netherlands | |
| Tel.: (+31) 43-408 6868 | |
| Fax: (+31) 43-408 6888 | |
| Contact person: | Mr. Pierre Vreuls |
| Manager Regulatory Affairs and Quality Assurance | |
| E-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 21 |
| CFR 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 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. |
. . . . . . .
- ·
1
K110422 p.2 of 3
Name and model numbers new devices:
| Predicate device Medtronic
Xomed [K031003] | Technomed Europe surgical
stimulators
[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 DIN | |
| 42802 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 surgical
stimulators | 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 DIN
42802 to DIN 42802 | 42307-001 |
| | Disposable subdermal needle
electrode | 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 DIN
42802 to DIN 42802 | 42307-001 |
| | Disposable subdermal needle
electrode | 40072-001 |
..
2
110422 p.3 of 3
| Intended Use: | 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. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to predicates: | The design, materials, chemical composition, packaging and
other technological characteristics of the subject device is
equivalent to those of the predicate devices. |
| Non-clinical data: | Technomed Europe has been bench testing the Kartush
disposable surgical stimulators to confirm performance
characteristics of this device. The bench testing consisted of
dimensional measurements to determine the current density,
impedance tests of the tips of the devices through saline, material
comparison and dielectric strength test of the shaft and handle
insulation. The conclusion of these bench tests is that the subject
devices 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 Kartush
disposable surgical
stimulators [proposed device] |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 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 |
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.
.
·
・・
:
. ...
3
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
4
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
5
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