XTOOL

K122861 · Ouroboros Medical · HRX · Dec 7, 2012 · Orthopedic

Device Facts

• Record ID: K122861
• Device Name: XTOOL
• Applicant: Ouroboros Medical
• Product Code: HRX · Orthopedic
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XTool™ Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

Device Story

XTool™ is a manual, handheld orthopedic surgical instrument for discectomy in open and minimally invasive spine procedures. Device consists of an angled cutting head with serrated edges, a distal guard, and a hollow shaft connecting to a proximal handle. Handle features a port for connection to standard hospital wall or pump suction. Two diameter options (5.2 mm or 6.3 mm) accommodate varying disc heights; two tip angles (15° or 40°) facilitate ipsilateral and contralateral access. During surgery, the surgeon uses the device to cut tissue, which is drawn into the tip opening via suction and aspirated through the stainless steel tube. Device aids in soft tissue cutting and cartilage removal, potentially improving surgical efficiency in spinal procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, biocompatibility testing per ISO 10993, sterilization validation per ISO 11137, packaging validation per ISO 11607-1, and simulated use cadaver testing to demonstrate intended functionality.

Technological Characteristics

Manual handheld surgical instrument; stainless steel construction; suction-assisted aspiration; 22 cm working length; 5.2 mm or 6.3 mm diameter; 15° or 40° tip angles. Compliant with ISO 10993 (biocompatibility), ISO 11137 (sterilization), and ISO 11607-1 (packaging).

Indications for Use

Indicated for patients undergoing open or minimally invasive spinal surgery requiring spinal discectomy, specifically for the cutting and removal of soft and hard tissue.

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

• Arthrojet/SpineJet (K041233)
• Laparoscopic Disc Removal System (K972768)

Submission Summary (Full Text)

{0}------------------------------------------------

# K/22861

## Section 5: 510(k) Summary

DEC 0 7 2012

| Category | Comments |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Ouroboros Medical, Inc.<br>47757 Fremont Blvd.,<br>Fremont, CA 94538 |
| Correspondent Contact<br>Information: | Shelley Trimm<br>Consultant, Regulatory Affairs<br>Ouroboros Medical, Inc.<br>47757 Fremont Blvd.,<br>Fremont, CA 94538<br>Tel: [phone]<br>Fax: [phone]<br>Email:[e-mail] |
| Device Common Name: | Arthroscope and Accessories |
| Device Classification &<br>Code: | Arthroscope: Class II, HRX<br>Arthroscope Accessories: Class I, NBH |
| Device Classification<br>Name: | 21 CFR § 888.1100 Arthroscope and<br>Accessories |
| Device Proprietary Name: | XTool™ MIS DISCECTOMY |

## Predicate Device Information:

| Predicate Devices: | Arthrojet/SpineJet | Laparoscopic Disc Removal<br>System |
|--------------------------------------------|-----------------------------|-------------------------------------|
| Predicate Device<br>Manufacturers: | HydroCision | Blackstone Medical Inc. |
| K#s | 041233 | 972768 |
| Predicate Device Common<br>Name: | Arthroscope and Accessories | Arthroscope and Accessories |
| Predicate Device<br>Classification: | 21 CFR § 888.1100 | 21 CFR § 888.1100 |
| Predicate Device<br>Classification & Code: | Arthroscope: Class II, HRX | Arthroscope: Class II, HRX |

### b. Date Summary Prepared

September 1, 2012

### Description of Device C.

The XTool™ is an orthopedic manual hand held surgical instrument for use in performing discectomy in open and minimally invasive spine procedures. It is composed of an angled cutting head with serrated cutting edges and a distal guard, and a hollow shaft that connects the cutting head to the handle proximal. The handle has a port for connecting to standard hospital wall or pump suction. Two different diameter devices are specified to accommodate the range of disc heights for which a discectomy can be performed, with the smaller diameter for lower height discs, and the larger diameter for larger height disc. Two different tip angles are also specified to facilitate ipsilateral and contralateral disc removal. The finished assembly working length is 22 cm, Tip Angle is 15° or 40° and the cutter head diameter is either 5.2 mm or 6.3 mm.

{1}------------------------------------------------

## Indications for Use

The XTool™ Device is indicated for spinal discectomy, procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

### Comparison to Predicate Device e.

The Ouroboros Medical XTool™ MIS DISCECTOMY Device is substantially equivalent in intended use and technology to the currently marketed predicate devices the HydroCision Arthrojet/SpineJet handpiece (K041233) and the Blackstone Medical Inc. Laparoscopic Disc Removal System (K972768). Both the Application device and the predicate devices provide a means to cut soft tissue, remove cartilage, and aspirate tissue through a stainless steel tube in spinal surgeries. The Arthrojet/SpineJet has a cutting blade () at the tip and a tip orifice that draw tissue in to be aspirated through the collection tube. The XTool™ Device also has a cutting blade at the tip with a tip opening for drawing in tissue to be aspirated through a stainless steel tube. The Blackstone Laparoscopic Disc Removal System also has cutting edges around an opening at the tip that draws tissue in using suction to be aspirated through the stainless steel tube.

### f. Summary of Supporting Data

Biocompatibility testing demonstrates that the device is in compliance with ISO 10993 for biocompatibility of the product.

Sterilization Validation has demonstrated that the device is in compliance with ISO 11137 standards for product sterility assurance.

Packaging Validation has demonstrated that the device is in compliance with ISO 11607-1.

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

Simulated use cadaver testing demonstrated that the device can be used as intended in humans.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Ouroboros Medical % Ms. Shelley Trimm Consultant, Regulatory Affairs 47757 Fremont Boulevard Fremont, California 94538

Re: K122861

Trade/Device Name: XTool™ MIS DISCECTOMY Device Regulation Number: 21 CFR 888.1100 · Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 18, 2012 Received: October 19, 2012

Dear Ms. Trimm:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

{3}------------------------------------------------

Page 2 -- Ms. Shelley Trimm

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.

# Peter D. Rumm -S

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

Enclosure

{4}------------------------------------------------

## Section 4: Indications for Use Statement

510(k) Number (if known): K122861

Device Name: XTool™ MIS DISCECTOMY Device

Indications For Use: The XTool™ Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

AND/OR Prescription Use X (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).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ l

Neil R Ogden 2012.12.03 11:56:08 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number