(34 days)
The Stimulus-Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, forceps, retractors, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are noninsulated stainless steel to provide for mechanical, manually actuated dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This 510(k) submission (K014163) for the Stimulation/Dissection Instruments does not contain explicit acceptance criteria or a dedicated study section detailing performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.
Summary of Device Performance and Substantial Equivalence:
The core of this submission is a comparison table outlining the characteristics of the Stimulus - Dissection Instruments and the predicate device, Ball-Tip Monopolar Stimulating Probe [K992869]. The "reported device performance" is essentially that the new device shares the same fundamental characteristics and intended use as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not stated, I will infer them from the characteristics listed for substantial equivalence. The "Reported Device Performance" will reflect that the new device meets these inferred criteria by being "Yes" where applicable.
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Stimulus - Dissection Instruments) |
|---|---|
| Indications For Use: Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | Yes (Shares same Indications For Use) |
| Construction: Stainless steel construction | Yes |
| Electrical Insulation: Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Yes |
| Patient Contact Surface: Distal stainless steel patient contact surface | Yes |
| Stimulator Connector: Proximal stimulator connector | Yes |
| Safety Standard Compliance: IEC 60601-1 Protected Pin design (21 CFR 898.12) | Yes |
| Biocompatibility: Biocompatible materials | Yes |
| Sterilization: Steam autoclavable | Yes |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable (N/A) for this type of submission. This submission does not include a dedicated clinical or performance study with a test set. The substantial equivalence argument relies on the comparison of design features and intended use with a predicate device.
- Data Provenance: N/A. There is no new data from a test set presented. The "data" here is descriptive of the device's design and functions, and a comparison to an existing, legally marketed device.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: N/A. No ground truth was established by experts for a test set, as no performance study was conducted.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A. No test set requiring ground truth adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. This submission does not describe an MRMC study or any comparative effectiveness study with human readers. The device is a surgical instrument with a stimulation function, not an AI-powered diagnostic tool. The focus is on the safety and effectiveness of the instrument itself, not on improving human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No. This device is a physical surgical instrument; it is not an algorithm, and therefore, a standalone algorithm performance study is not relevant or included.
7. Type of Ground Truth Used:
- Type of Ground Truth: N/A. No ground truth in the context of a performance study (e.g., pathology, outcomes data, expert consensus on diagnostic findings) was used. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device and relevant standards (e.g., IEC 60601-1).
8. Sample Size for the Training Set:
- Sample Size for Training Set: N/A. This device does not involve machine learning or AI, so there is no "training set."
9. How Ground Truth for Training Set Was Established:
- How Ground Truth Was Established: N/A. As there is no training set, this is not applicable.
Conclusion:
This 510(k) submission for the Stimulation/Dissection Instruments is a substantial equivalence submission, a common pathway for medical devices. It does not present a performance study with explicit acceptance criteria or a test set. Instead, it successfully argues that the new device is as safe and effective as a legally marketed predicate device by demonstrating that its design, technology, features, function, and intended use are substantially equivalent. The "acceptance criteria" are effectively the characteristics of the predicate device that define its safety and effectiveness, which the new device is shown to share.
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KO14163
510(k) Summary
JAN 2 2 2002
1.0 Date Prepared
January 14, 2002
Submitter (Contact) 2.0
Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586
3.0 Device Name
| Proprietary Name: | Stimulation / Dissection Instruments (Tradenames have not beenfinalized at this time) |
|---|---|
| Common Name(s): | Nerve Stimulator / Locator |
| Classification Name(s): | Surgical Nerve Stimulator / Locator |
Device Classification 4.0
| Classification Name: Surgical Nerve Stimulator / Locator and accessories | ||
|---|---|---|
| Procode 77ETN | Class II | 21 CFR § 874.1820 |
| Procode Various | Class I | 21 CFR § 874.4420 |
| Procode Various | Class I | 21 CFR § 878.4800 |
Device Description 5.0
The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, forceps, retractors, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are noninsulated stainless steel to provide for mechanical, manually actuated dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.
6.0 Indications for Use
The Stimulus-Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
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510(k) Summary (continued)
Substantial Equivalence 7.0
The design, technology, features, function, and intended use of the intraoperative neurological stimulation feature of the Stimulus-Dissection Instrument is substantially equivalent to Medtronic Xomed Monopolar Stimulator Probe originally described in K992869.
The design, technology, features, function, and intended use of the mechanical dissection feature is substantially equivalent to Class I exempt manual surgical instruments such as those described in 21 CFR § 874.4420 and 21 CFR § 878.4800.
| Characteristic | Stimulus - Dissection Instruments | Ball-Tip MonopolarStimulating Probe [K992869] |
|---|---|---|
| Indications ForUse | Tissue dissection and stimulation ofcranial and peripheral motor nervesfor location and identificationduring surgery, including spinalnerve roots. | To stimulate cranial andperipheral motor nerves forlocation and identification duringsurgery, including spinal nerveroots. |
| Stainless steelconstruction | Yes | Yes |
| Electricalinsulation | Electrical insulation on all surfacesnot intended to provide electricalcontact with the patient | Electrical insulation on allsurfaces not intended to provideelectrical contact with the patient |
| Distal stainlesssteel patientcontact surface | Yes | Yes |
| Proximalstimulatorconnector | Yes | Yes |
| IEC 60601-1Protected Pindesign | Yes | Yes |
| Biocompatible | Yes | Yes |
| Steamautoclavable | Yes | Yes |
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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Medtronic Xomed, Inc. c/o Martin D. Sargent 6743 Southpoint Dr. North Jacksonville, FL 32216
Re: K014165
Trade/Device Name: Stimulation/Dissection Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: December 18, 2002 Received: December 19, 2002
Dear Mr. Sargent:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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16014165 510(k) Number (if known): __ Stimulus - Dissection Instruments Device Name: Indications for Use:
.
The Stimulus - Dissection Instruments are indicated for tissue dissection and stimulation of cranial and periph-I he Stimulus - Dissection insulance are indicated for about the research of the spinal nerve roots.
(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)
Or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Karen Bahr '41
(Division Sign-Off) Division of Ophthalmic Ea Nose and Throat Devis
510(k) Number K014165
§ 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.