MASS (MICRO-ACCESS SPINE SYSTEM)

K992583 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · HRX · Oct 29, 1999 · Orthopedic

Device Facts

• Record ID: K992583
• Device Name: MASS (MICRO-ACCESS SPINE SYSTEM)
• Applicant: Omni-Tract Surgical, Div. Minn. Scientific, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.

Device Story

The Micro-Access Spine System (MASS) is a manually adjusted surgical retractor system used in spinal surgery. The system consists of a single-piece retractor/access port, a fiber optic light cable accessory, two sets of four varying-sized dilators, and assorted manual surgical instruments with handles designed to conform to the retractor/access port. The device is operated by a surgeon in a clinical setting to provide access to the surgical site. It functions as a mechanical tool to maintain exposure during procedures. No electronic processing or automated decision-making is involved.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manually adjusted retractor system. Components include a single-piece retractor/access port, fiber optic light cable, and dilators. Materials are consistent with predicate OMNI-TRACT systems. No electronic energy source or software.

Indications for Use

Indicated for patients undergoing spinal surgery requiring access via a retractor system consistent with the device's working dimensions.

Regulatory Classification

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.

Predicate Devices

• OMNI-TRACT Surgical Retractor Systems (K842762)
• OMNI-TRACT Surgical Retractor Systems (K853947)
• OMNI-TRACT Surgical Retractor Systems (K872919)

Submission Summary (Full Text)

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K992583

## Appendix 4

## Summary of Safety and Effectiveness

| Submitter: | OMNI-TRACT Surgical Inc.<br>Division of Minnesota Scientific, Inc.<br>1100 New Brighton Blvd.<br>Minneapolis, MN 55413<br>Telephone: [phone] | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Product: | Classification Name: | Orthopedic Manual Surgical Instrument<br>(21 CFR 888.4540) |
| | Common Name: | Surgical Retractor System |
| | Trade/Proprietary Name: | MASS (Micro-Access Spine System) |
| Substantially<br>Equivalent<br>Products | OMNI-TRACT Surgical Retractor Systems (K842762, K853947 and<br>K872919) and other commercially distributed devices. | |
| Description: | The device a manually adjusted retractor system. It has a single- piece<br>retractor/access port, fiber optic light cable accessory, 2 sets of 4 varying-sized<br>dilators and assorted manual surgical instruments whose handles conform to<br>the shape of the retractor/access port. | |
| Intended<br>Use: | The intended use is for spinal surgery that is consistent with the working<br>dimensions of the retractor/access port. | |
| Comparison<br>to Substantial<br>Equivalent<br>Products | Predicate devices have the same intended use, principle or operation, general<br>design and materials. Differences between the new and predicate devices<br>were subjected to bench, cleaning and sterilization testing to demonstrate that<br>they 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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