TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

K032891 · Trans1, Inc. · HRX · Jan 15, 2004 · Orthopedic

Device Facts

• Record ID: K032891
• Device Name: TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
• Applicant: Trans1, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny or for assistance in the performance of L5-S1 interbody fusion.

Device Story

The TranS1 Trans-Sacral Spinal Access and Preparation Device provides minimally invasive access to the anterior lower spine. The kit includes guide pins, dilators, drills, cutters, brushes, and insertion tools. It is used by surgeons to create an access tract to the anterior region of the lower spine, enabling procedures such as biopsy, lumbar fusion, and vertebroplasty up to the L5 level. The device facilitates surgical access, allowing the clinician to perform spinal interventions through a minimally invasive approach, potentially reducing tissue trauma compared to traditional open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical instrument set for minimally invasive spinal access. Components include guide pins, dilators, drills, cutters, and insertion tools. Designed for access up to L5. Non-powered, manual instrumentation.

Indications for Use

Indicated for patients requiring minimally invasive access to the anterior lower spine for treatment of lumbar disc degeneration, lumbar discectomy, or L5-S1 interbody fusion.

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

• AxiaMed, Inc., Trans-Sacral Spinal Access Device
• Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit
• Argus Medical Company Laparoscopic Discectomy Instrument System
• Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter
• Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter
• Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System
• United States Surgical, Auto Suture Spinal Elevator
• Harrington Spinal Elevator
• Karlin Technology, Inc., Cobb Spinal Elevator

Submission Summary (Full Text)

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JAN 1 5 2004

032891 1 1/2

## 510(k) Summary of Safety and Effectiveness

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

- TranSl, Inc. 1. Name: 1800 Sir Tyler Drive Address: Suite 101 Wilmington, NC 28405
Phone; 910 509-3100 Fax: [phone]

W. Allen Putnam Contact: Date of Summary Preparation: January 12, 2004

- Name of Device: Trans 1 Trans-Sacral Spinal Access and Preparation Device 2. Generic Name: Rigid Endoscope and Instrument Set
- 3. Predicate Devices:

AxiaMed. Inc., Trans-Sacral Spinal Access Device

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

Argus Medical Company Laparoscopic Discectomy Instrument System

Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter

Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter

Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System

United States Surgical, Auto Suture Spinal Elevator

Harrington Spinal Elevator

Karlin Technology, Inc., Cobb Spinal Elevator.

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

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- Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool
- Indication for use: રું .

The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny or for assistance in the performance of L5-S1 interbody fusion.

- Technological Characteristics of the Device: 6.
The TranS1 Trans-Sacral Spinal Access and Preparation Device is designed to gain a minimally invasive access tract to the anterior region of the lower spine and assist in the diagnosis and treatment of the area. This would enable procedures such as biopsy, lumbar fusion, vertebroplasty, etc. The access devices are of such length that access up to L5 is possible.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized graphic of three wavy lines, which may represent the flow of information or services.

JAN 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TranS1, Inc. c/o Mr. W. Allen Putnam RCQ Strategies 6285 Chaska Road Excelsior, Minnesota 55331

Re: K032891

Trade/Device Name: TranS1 Trans-Sacral Spinal Access and Preparation Kit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: December 15, 2003 Received: December 16, 2003

Dear Mr. Putnam:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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). and Cosmeter For (110) the the device, subject to the general controls provisions of the Act. The r ou may more over sections 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 may be subject to such addressar enulations, 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 I least of advised that I Dr is issualso over device complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of any I coleral stututes and regulations, including, but not limited to: registration and listing (21 Comply with an the Act STequirements, assisted on the of manufacturing practice requirements as set CI N Fart 607), additig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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) I mis letter will and w you to organization of substantial equivalence of your device to a legally prematics notification: "The Province and thus, pour 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 If you desire specific advision at [phone]. Also, please note the regulation entitled, Contact the Office of Companies as the transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

iriam C. Provost

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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## Indications for Use

510(k) Number (if known): K032891

TranS1 Trans Sacral Spinal Access and Preparation Kit

Indications For Use:

Device Name:

The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of LS-S1 interbody fusion.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

Sion Sign-Off) Tivision of General, Restorative Ad Neurologi

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