AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE

K020457 · Axiamed, Inc. · HRX · Sep 26, 2002 · Orthopedic

Device Facts

• Record ID: K020457
• Device Name: AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
• Applicant: Axiamed, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Sep 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.

Device Story

The AXIAMED Trans-Sacral Spinal Access Device is a set of surgical instruments designed for minimally invasive access to the anterior lower spine. The system includes a blunt trocar, trocar guide stylet, threaded guide dilators (small and large), threaded guide sheaths (3mm and 4mm), drill bits (3mm and 4mm), and a delivery cannula with a blunt stylet. Used by surgeons in a clinical or operating room setting, these instruments facilitate access to the lumbar spine to assist in decompression or discectomy procedures. The device provides a mechanical pathway for the surgeon to reach the target site, potentially reducing the invasiveness of the procedure compared to traditional open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device consists of a set of rigid surgical instruments including trocars, dilators, sheaths, drill bits, and a delivery cannula. It is a mechanical, non-powered system designed for manual operation by a surgeon. Materials and specific ASTM standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring minimally invasive access to the anterior lower spine for lumbar disc decompression or lumbar discectomy.

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

• Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit for Discectomy
• Argus Medical Company Laparoscopic Discectomy Instrument System
• The Nucleotome System and Probe Kits
• Surgical dynamics Discography System
• Sofamor Danek USA, Inc., Micro Endo Instruments

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

In Accordance with CFR 807.92 (April 26, 1992), the following information is submitted:

| 1. | Name: | AXIAMED, Inc. |
|----|----------|---------------------------------------------------|
| | Address: | 5200 Willson Road<br>Suite 150<br>Edina, MN 55424 |

952 836-2660 Phone: [phone] Fax:

W. Allen Putnam Contact: Date of Summary Preparation: July 12, 2002

- Name of Device: AXIAMED Trans-Sacral Spinal Access Device 2. Generic Name: Rigid Endoscope and Instrument Set
- 3. Predicate Devices:

Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit for Discectomy

Argus Medical Company Laparoscopic Discectomy Instrument System

The Nucleotome System and Probe Kits.

Surgical dynamics Discography System

Sofamor Danek USA, Inc., Micro Endo Instruments

- Device Description: 4.
The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components:

Blunt Trocar with Trocar Guide Stylet Threaded Guide Dilator Sheath, Small Dilator Sheath, Large Threaded Guide Sheath, 3mm Threaded Guide Sheath, 4mm Drill Bit, 3 mm Drill Bit, 4mm Delivery Cannula with blunt stylet

Kc20457

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration . 9200 Corporate Boulevard Rockville MD 20850.

SEP 2, 6 2002

Mr. W. Allen Putnam AXIAMED, Inc. 5200 Wilson Road, Suite 150 Edina, Minnesota 55424

Re: K020457

Trade Name: AXIAMED Trans-Sacral Spinal Access Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 12, 2002 Received: July 15, 2002

Dear Mr. Putnam:

We have reviewed your Section 510(k) premarket 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) 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 (OS) 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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Page 2 – Mr. W. Allen Putnam

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 and additionally 21 CFR Part 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Atypt Rhodes
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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020457

## INDICATION FOR USE

The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.

Hyde Rhode

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________