LIGHT SABRE SPINAL ACCESS DEVICE

K071814 · Minrad, Inc. · KNW · Oct 16, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071814
• Device Name: LIGHT SABRE SPINAL ACCESS DEVICE
• Applicant: Minrad, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.

Device Story

Light Sabre™ Spinal Access Device is a single-use, disposable biopsy needle and spinal access tool. It consists of a stainless steel stylet and cannula with plastic hubs and a removable handle. The device integrates a collimating channel and light-dispersing element within the stylet assembly. It is designed for use with the MINRAD SabreSource™ Targeting System. When the device is aligned with the SabreSource™ laser beam, the light-dispersing element illuminates; movement out of the laser path causes the glow to cease. This visual feedback assists clinicians in maintaining correct orientation during percutaneous spinal procedures. The device facilitates bone/bone marrow biopsy and provides a port for guidewire placement. It includes a stainless steel core sampler for biopsy retrieval and a Luer lock adapter for aspiration or injection. Used in clinical settings by physicians, the device improves procedural accuracy by providing real-time visual confirmation of device positioning relative to the targeting laser.

Clinical Evidence

Bench testing only. Materials were evaluated for biological safety per ISO 10993 standards. Performance testing was conducted in accordance with industry-recognized methods applicable to biopsy needles and spinal access devices.

Technological Characteristics

Materials: Stainless Steel 304, Gamma-stable Polycarbonate. Dimensions: 10-15cm length; 8, 11, 13 Gauge. Principle: Mechanical biopsy needle with integrated optical alignment (collimating channel/light-dispersing element) for use with external laser targeting system. Connectivity: None (passive optical alignment). Sterilization: Gamma radiation. Standards: ASTM F1140-00, ISO 11137, ISO 11737, ISO 10993-1/5/10, ISO 9626, ISO 594, ISO 11607, ASTM F88-06, ASTM D-5276-98.

Indications for Use

Indicated for patients requiring bone or bone marrow biopsy or percutaneous spinal procedures involving guidewire placement.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Light Sabre™ Bone Biopsy Needle (K982735)

Submission Summary (Full Text)

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## PREMARKET NOTIFICATION 510(k)

Ko71814

| 5.0 | 510(k) Summary or 510(k) Statement | | OCT 16 2007 |
|-----|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | <div align="center">MINRAD</div> | | |
| | | 510(k) Summary | |
| 1. | 510(k) owner's name: | Minrad, Inc. | |
| 2. | Address: | 50 Cobham Drive<br>Orchard Park, NY 14127<br>Phone: [phone]<br>Facsimile: [phone] | |
| | Contact: | John McNeirney,<br>Senior Vice President & Chief Technical Officer | |
| 3. | Preparation Date: | June 29, 2007 | |
| 4. | Device name: | Light Sabre™ Spinal Access Device | |
| 5. | Common name: | Biopsy Needle | |
| 6. | Product classification: | Instrument, Biopsy (21 CFR 876.1075, Product Code KNW) | |
| 7. | Predicate device: | Light Sabre™ Bone Biopsy Needle (K982735) | |
| 8. | Description of device: | The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market | |
| | Minrad, Inc.<br>50 Cobham Drive | 12 of 45 | |

50 Cobham Drive Orchard Park, NY 14127

CONFIDENTIAL

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# PREMARKET NOTIFICATION 510(k)

| | under K022935. To do this, the Light Sabre™ Spinal<br>Access Device incorporates a collimating channel and<br>light-dispersing element directly into the stylet assembly.<br>When the Light Sabre™ Spinal Access Device is aligned<br>with the laser beam of the SabreSource™ Targeting<br>System, the laser will clearly illuminate the light-<br>dispersing element. Whenever the device is moved out of<br>the path, as defined by the laser beam, the light-<br>dispersing element of the Light Sabre™ Spinal Access<br>Device ceases to glow. | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9.<br>Voluntary<br>standards: | There are not any specific standards promulgated but the<br>Light Sabre™ Spinal Access Device will be<br>manufactured in accordance with following standards:<br>1. ASTM F1140-00<br>2. ANSI/AAMI/ISO 11137:1994<br>3. ANSI/AAMI/ISO 11737-1:1995<br>4. AAMI TIR 17:1997<br>5. AAMI TIR 27:2001<br>6. ANSI/AAMI/ISO TIR 15843:2000<br>7. ANSI/AAMI ST 72:2002<br>8. ASTM D-5276-98(2004)<br>9. ASTM F88-06<br>10. ISO 11607<br>11. ISO 9626:1991<br>12. ISO 594:1986<br>13. ISO 10993-1:2003<br>14. ISO 10993-5:1999<br>15. ISO 10993-10:2002 | |
| 10. Intended use and<br>indication for use: | The Light Sabre™ Spinal Access Device is a single-use<br>disposable device that is used to obtain biopsies of bone<br>and/or bone marrow and is used to provide a port of entry<br>to place guidewires during percutaneous spinal<br>procedures. | |
| 11.<br>Technological<br>characteristics: | Indications for Use: A single-use disposable device that<br>is used to obtain biopsies of bone and/or bone marrow<br>and is used to provide a port of entry to place guidewires<br>during percutaneous spinal procedures.<br>Sterility: Provided sterile for single use<br>Needle Type: Cannula - Stainless Steel with Plastic Hub<br>Assembly; Stylet - Stainless Steel with Plastic Hub<br>Assembly | |
| Needle Length: 10 - 15cm | | |
| Needle Gauge/Diameter: 8, 11, 13 Gauge | | |
| Stainless Steel Material: Stainless Steel 304 | | |
| Stylet/Cannula Hub Material: Gamma Stable | | |
| Polycarbonate | | |
| Method of Sterilization: Gamma Radiation | | |
| Includes method to remove biopsy sample: Included | | |
| in Packaging is Core Sampler made of Stainless Steel | | |
| 304 | | |
| Able to connect Syringe for Aspiration or Injection: | | |
| Luer Lock per ISO 594-2:1998 (E) on Luer Adapter | | |
| Component | | |
| 12. | Testing | All materials used in the fabrication of the Light Sabre™<br>Spinal Access Device will be evaluated through<br>biological qualification safety tests as outlined in the<br>applicable sections of ISO 10993. These materials will<br>also be tested in accordance with industry recognized test<br>methods that are applicable based on the intended use of<br>the device. |

50 Cobham Drive Orchard Park, NY 14127 of 45

**CONFIDENTIAL**

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## PREMARKET NOTIFICATION 510(k)

This concludes the 510(k) summary.

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Minrad, Inc. 50 Cobham Drive Orchard Park, NY 14127

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CONFIDENTIAL

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Image /page/3/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 symbol, with three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

OCT 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Minrad, Inc. % Mr. John McNeirney Senior VP and Chief Technical Officer 50 Cobham Drive Orchard Park, New York 14127

Re: K071814

Trade/Device Name: Light Sabre™ Spinal Access Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: August 30, 2007 Received: September 7, 2007

Dear Mr. McNeirney:

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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### PREMARKET NOTIFICATION 510(k)

#### Indications for Use Statement 4.0

510(k) Number (if known):

Device Name: Light Sabre™ Spinal Access Device

Indications for Use:

The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.

Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Division Sign-Division of General, Restorative, nd Neurological Devices

Number 1671814

Minrad, Inc. 50 Cobham Drive Orchard Park, NY 14127 11 of 45

CONFIDENTIAL

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