VERTOS MEDICAL MILD DEVICE KIT

K093062 · X-Sten Corp. · HRX · Feb 4, 2010 · Orthopedic

Device Facts

• Record ID: K093062
• Device Name: VERTOS MEDICAL MILD DEVICE KIT
• Applicant: X-Sten Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

Device Story

The Vertos Medical mild® Device Kit consists of specialized arthroscopic surgical instruments used by surgeons to perform lumbar decompressive procedures. The kit is supplied sterile for single-use. The instruments are designed to facilitate the removal of tissue to decompress the lumbar spine. The device is used in a clinical or surgical setting. By enabling minimally invasive decompression, the kit aims to treat spinal conditions, potentially reducing patient recovery time and surgical trauma compared to traditional open procedures.

Clinical Evidence

No clinical data provided. Evidence consists of biocompatibility evaluation (ISO 10993 compliance), bench testing against pertinent standards, and cadaveric testing to confirm usability in accordance with the Indications for Use.

Technological Characteristics

Set of specialized arthroscopic surgical instruments. Materials are biocompatible per ISO 10993. Supplied sterile for single-use. Manual operation.

Indications for Use

Indicated for patients requiring lumbar decompressive procedures for the treatment of various spinal conditions.

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

• X-Sten MILD Tool Kit (K062038)
• Ultra Low Profile Rongeur & Access Tools (K062711)

Submission Summary (Full Text)

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K093062

Image /page/0/Picture/1 description: The image shows the logo for Vertos Medical, Inc. The word "Vertos" is written in a bold, sans-serif font, with a stylized spine symbol inside the "o". Below the word "Vertos" is the text "MEDICAL, INC." in a smaller, sans-serif font. The logo is black and white.

Vertos Medical mild® Device Kit Modification Premarket Notification

| Device Information: | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor: | Vertos Medical, Inc.<br>2362 Qume Drive, Suite D<br>San Jose, CA 95131<br>Tel: [phone]<br>Fax: [phone] |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Arthroscopic Accessories |
| Device Classification Number: | 21 CFR 888.1100 |
| Device Classification &<br>Product Code: | Class II,<br>HRX |

# Section 5: 510(k) Summary

FEB - 4 2010

# Predicate Device Information:

Device Proprietary Name:

| Predicate Device: | X-Sten MILD Tool Kit |
|----------------------------------------------------|---------------------------------------------|
| Predicate Device Manufacturer: | X-Sten (renamed as Vertos Medical, Inc.) |
| Predicate Device Common Name: | Arthroscopic Accessories |
| Predicate Device Premarket Notification # | K062038 |
| Predicate Device Classification: | 21 CFR 888.1100 |
| Predicate Device Classification & | Class II, |
| Product Code: | HRX |
| Predicate Device: | Ultra Low Profile Rongeur & Access<br>Tools |
| Predicate Device Manufacturer: | Baxano, Inc |
| Predicate Device Common Name: | Manual Rongeur |
| Predicate Device Premarket Notification # | K062711 |
| Predicate Device Classification: | 21 CFR 882.4840 |
| Predicate Device Classification &<br>Product Code: | Class II,<br>HAE |

Vertos Medical mild® Device Kit

# b. Date Summary Prepared

4 February 2010

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### c. Description of Device

The Vertos Medical mild® Device Kit is a set of specialized arthroscopic surgical instruments. They are supplied sterile, for single use only.

#### d. Indications for Use

The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

### e. Comparison to Predicate Device

The Vertos Medical mild® Device Kit is substantially equivalent to the X-Sten MILD Tool Kit (K062038) and the Baxano Ultra Low Profile Rongeur and Access Tools (K062711) in intended use, technology, design and patient contacting materials

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

Company concludes that the devices are substantially equivalent.

### f. Summary of Supporting Data

Biocompatibility evaluation demonstrates that the devices are in compliance with ISO 10993.

Bench testing has demonstrated that the devices are in compliance with pertinent standards, the expectations of the medical community and the product labeling.

Cadaveric testing demonstrated that the devices in Vertos Medical mild® Device Kit can be used in accordance with the Indications for Use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or extensions, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vertos Medical, Inc. % Coombs Medical Device Consulting Mr. Craig Coombs President 1193 Sherman Street Alameda, California 94501

Re: K093062

Trade/Device Name: Vertos Medical mild® Device Kit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HAE Dated: January 29, 2010 Received: February 01, 2010

Dear Mr. Coombs:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

FEB - 4 2010

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Craig Coombs

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

fin Cart

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the logo for Vertos Medical, Inc. The logo consists of the word "Vertos" in a bold, sans-serif font, with a stylized image of a spine within a circle to the right of the word. Below the word "Vertos" is the text "MEDICAL, INC." in a smaller, sans-serif font.

# Section 4: Indications for Use Statement

510(k) Number (if known): K 093062

Vertos Medical mild® Device Kit Device Name:

Indications For Use:

The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

M.R. Kumar

(Division Sign-Off) (Division Sign-Q1)
Division of Surgical, Orthopedic, Division of Surg.
and Restorative Devices

Restorative Devices
/k093062
510(k) Number