(88 days)
The intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.
The device a manually adjusted retractor system. It has a single- piece retractor/access port, fiber optic light cable accessory, 2 sets of 4 varying-sized dilators and assorted manual surgical instruments whose handles conform to the shape of the retractor/access port.
This document is a 510(k) premarket notification for a medical device called the "Micro-Access Spine System" (MASS). The FDA's letter states that the device is substantially equivalent to previously marketed devices and permits it to be marketed.
However, the provided text does not contain any information regarding acceptance criteria or the study that proves the device meets specific acceptance criteria.
The document primarily focuses on:
- Device Identification: Product name, classification, common name, trade name.
- Submitter Information: Company details.
- Predicate Devices: Listing of similar devices to which the MASS is compared for substantial equivalence.
- Description of the Device: Briefly describes components (retractor/access port, fiber optic light cable, dilators, surgical instruments).
- Intended Use: For spinal surgery consistent with the working dimensions of the retractor/access port.
- Comparison to Predicate Products: States that predicate devices have the same intended use, principle of operation, general design, and materials. It also mentions that "Differences between the new and predicate devices were subjected to bench, cleaning and sterilization testing to demonstrate that they do not affect safety and effectiveness."
There is no detailed information on:
- Specific acceptance criteria for performance, safety, or effectiveness.
- The design or results of any studies (bench, clinical, or otherwise) that measure the device's performance against quantifiable criteria.
- Sample sizes for tests, data provenance, expert involvement for ground truth, or adjudication methods for studies.
- Any multi-reader multi-case (MRMC) or standalone algorithm performance studies (as this is a manual surgical instrument, not an AI/software device).
- How ground truth was established for any hypothetical training set.
Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and study details because that information is not present in the provided text. The document confirms that bench, cleaning, and sterilization testing were performed on differences between the new and predicate devices to demonstrate they do not affect safety and effectiveness, but it doesn't elaborate on the criteria or results of these tests.
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Appendix 4
Summary of Safety and Effectiveness
| Submitter: | OMNI-TRACT Surgical Inc.Division of Minnesota Scientific, Inc.1100 New Brighton Blvd.Minneapolis, MN 55413Telephone: (612) 623-0396 | |
|---|---|---|
| Product: | Classification Name: | Orthopedic Manual Surgical Instrument(21 CFR 888.4540) |
| Common Name: | Surgical Retractor System | |
| Trade/Proprietary Name: | MASS (Micro-Access Spine System) | |
| SubstantiallyEquivalentProducts | OMNI-TRACT Surgical Retractor Systems (K842762, K853947 andK872919) and other commercially distributed devices. | |
| Description: | The device a manually adjusted retractor system. It has a single- pieceretractor/access port, fiber optic light cable accessory, 2 sets of 4 varying-sizeddilators and assorted manual surgical instruments whose handles conform tothe shape of the retractor/access port. | |
| IntendedUse: | The intended use is for spinal surgery that is consistent with the workingdimensions of the retractor/access port. | |
| Comparisonto SubstantialEquivalentProducts | Predicate devices have the same intended use, principle or operation, generaldesign and materials. Differences between the new and predicate deviceswere subjected to bench, cleaning and sterilization testing to demonstrate thatthey do not affect safety and effectiveness. |
.
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Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus-like symbol with three lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Ms. Cathy Miller Regulatory Affairs Manager Omni-Tract Surgical Division of Minnesota Scientific, Inc. 1100 New Brighton Boulevard Minneapolis, Minnesota 55413-1660
K992583 Re: Trade Name: Micro-Access Spine System Regulatory Class: II Product Code: HRX Dated: July 27, 1999 Received: August 2, 1999
Dear Ms. Miller:
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 requirement, 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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Page 2 - Ms. Cathy Miller
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Xunelli S. Saja
Jur Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K-992583
Device Name: Micro-Access Spine System
FDA's Statement of the Indications For Use for device:
The intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.
Prescription Use _X (Per 21 CFR 801.109)
Russell H. Taylor Jr. Cmr
Wision Sinn-Of
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.