(117 days)
Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only.
The design of the Rhythmlink International Monopolar Stimulating Instrument is similar to existing stainless steel stimulating instruments. The device consists of a stainless steel wire with biocompatible electrical insulation applied to selected portions, and proximal connector provided to attach the instruments to a monopolar stimulator. The distal surface of the instrument is non-insulated stainless steel to provide for tissue stimulation. The Rhythmlink International Monopolar Stimulating Instrument with cable assembly is a protected pin design and meets requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.
The provided text is related to a 510(k) submission for a medical device called the "Rhythmlink International Monopolar Stimulating Instrument." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study with strict acceptance criteria and performance evaluation against those criteria. In these types of submissions, the "acceptance criteria" are often focused on showing that the new device is as safe and effective as the predicate device by meeting recognized standards and performing similar to the predicate under testing.
Here's an analysis based on the provided text, recognizing that it's a 510(k) summary and not a comprehensive study report:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of acceptance criteria with specific quantitative thresholds for device performance. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device and adherence to relevant standards.
The key reported performance-related aspect is:
- IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12: The device (Rhythmlink International Monopolar Stimulating Instrument with cable assembly) meets the requirements of this electrical safety standard, specifically Clause 56.3(c) regarding protected pin design.
Acceptance Criteria (Implied from 510(k) context):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K031003) | Claimed and accepted by FDA |
| Compliance with IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) | Device meets requirements for protected pin design. |
| Sterility and Single Use | Stated in Indications for Use. |
| Functionality as a Monopolar Stimulating Instrument | Device described as similar to existing instruments. |
| Biocompatibility of materials | Stainless steel with biocompatible electrical insulation. |
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 provide information on a specific clinical "test set" with a defined sample size for performance evaluation in the way a diagnostic device might. The evaluation is focused on engineering and electrical safety standards compliance and comparison to a predicate device. Therefore, details like data provenance (country, retrospective/prospective) are not applicable in this context.
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 as the submission is for a surgical stimulating instrument (Class II) and not a diagnostic device requiring complex ground truth establishment by medical experts for performance evaluation in a clinical setting. The "ground truth" here relates to engineering specifications and electrical safety standards rather than clinical diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated in point 3. There was no clinical test set 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
This is not applicable. The device is not an AI-assisted diagnostic tool or an imaging device, but rather a direct surgical instrument used for nerve stimulation. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is primarily derived from:
- Engineering specifications and standards: Specifically, compliance with IEC 60601-1 for electrical safety.
- Performance of the predicate device: The fundamental "ground truth" for a 510(k) is that the device performs at least as safely and effectively as the legally marketed predicate device (Medtronic Xomed Stimulation/Dissection Instruments, K031003).
8. The sample size for the training set
This is not applicable. As a physical surgical instrument, there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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K07236
5. 510(k) Summary
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Company Name: | Rhythmlink International, LLC1256 First Street South ExtensionColumbia, SC 29209 |
| Phone: 803-252-1222 | |
| FDA Registration #: 1067162 | |
| JAN 22 2008 | |
| Official Contact Person: | James M. Mewborne, Engineering and Regulatory Manager |
| Summary Date: | September 21, 2007 |
| Device Identification: | Proprietary Device Name:Rhythmlink International Monopolar Stimulating Instrument (Tradenames have not been finalized at this time) |
| Generic Device Name:Nerve Stimulator/Locator | |
| Regulatory Class: Class II | |
| Classification Name: 21 CFR 874.1820, Surgical nervestimulator/locator | |
| This device has not been previously submitted to the FDA. | |
| Predicate Device(s): | 510(k) Number: K031003 |
| Manufacturer: Medtronic Xomed | |
| Trade Name: Stimulation/Dissection Instruments | |
| Product Code: 874.1820 | |
| Device Description: | The design of the Rhythmlink International Monopolar StimulatingInstrument is similar to existing stainless steel stimulating instruments.The device consists of a stainless steel wire with biocompatibleelectrical insulation applied to selected portions, and proximalconnector provided to attach the instruments to a monopolar stimulator.The distal surface of the instrument is non-insulated stainless steel toprovide for tissue stimulation. The Rhythmlink InternationalMonopolar Stimulating Instrument with cable assembly is a protectedpin design and meets requirements of IEC 60601-1:1988 /A1:1991/A2:1995 Clause 56.3(c) per 21 CFR 898.12. |
| Indications for Use: | Rhythmlink International Monopolar Stimulating Instrument isindicated for stimulation of cranial and peripheral motor nerves forlocation and identification during surgery, including spinal nerve roots.The Rhythmlink International Monopolar Stimulating Instrument issterile and for single use only. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
JAN 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rhythmlink International, LLC c/o James Mewborne Engineering and Regulatory Manager 1256 First Street South Extension Columbia, SC 29209
Re: K072736
Trade/Device Name: Rhythmlink Monopolar Stimulating Instrument Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Mewborne:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
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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 marketed 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malina B. Eyler, ud
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: Rhythmlink International Monopolar Stimulating Instrument
Indications For Use: Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar Stimulating Instrument is sterile and for single use only.
Prescription Use × (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)
Kouett. booke
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K072736
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§ 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.