REPROCSSED LINVATEC SHAVERS

K012613 · Alliance Medical, Inc. · HRX · Nov 7, 2001 · Orthopedic

Device Facts

• Record ID: K012613
• Device Name: REPROCSSED LINVATEC SHAVERS
• Applicant: Alliance Medical, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Device Story

Reprocessed arthroscopic shavers consist of a burr or blade at the end of a long rod rotating within a hollow stainless steel housing. The housing features a distal window for tissue/bone excision while protecting adjacent structures. The device attaches to a motorized handpiece that provides rotational drive and suction to remove cut tissue from the surgical site. Used by surgeons in orthopedic, maxillofacial, hand, foot, and plastic surgical procedures. The device functions by mechanical abrasion, cutting, and excision of tissue and bone, or removal of loose fragments and debris. Reprocessing restores the device to its original intended performance specifications, providing a cost-effective alternative to new devices while maintaining clinical utility for tissue removal.

Clinical Evidence

Bench testing only. Performance was demonstrated through biocompatibility validation and functionality testing to ensure the reprocessed devices meet original specifications.

Technological Characteristics

Stainless steel housing with internal rotating burr or blade. Mechanical drive system via motorized handpiece. Dimensions, materials, and mechanical design are identical to original Linvatec predicate devices. Sterilization is performed as part of the reprocessing cycle.

Indications for Use

Indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

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

• Linvatec® Merlin Polyblade Shavers (K940515)
• Linvatec® Universal Drive System (K971059)
• Linvatec® Universal Drive System (K981269)
• Linvatec® Integrated Drive/Pump System (K981636)
• Linvatec® E9000 System (K990524)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Alliance Medical Corporation. The logo consists of three curved lines above the company name. The lines are thick and black, and they are arranged in a semi-circular shape. The text "ALLIANCE MEDICAL CORPORATION" is written in a serif font.

## Kola 613

# PART B: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

10232 South 51st Street Phoenix, Arizona 85044

TEL [phone]
FAX [phone] Toll Free 888.888.3433 www.alliance-medical.com

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Don Selvey<br>Vice President, Regulatory Affairs and Quality Assurance<br>[phone] |
| Date of preparation: | August 10, 2001 |
| Name of device: | Trade/Proprietary Name: Reprocessed Arthroscopic Shavers<br>Common or Usual Name: Arthroscopic Shaver<br>Classification Name: Arthroscope |

### Reprocessed devices:

| Manufacturer | Description | Model |
|----------------------|--------------------------------|-------|
| Linvatec Corporation | Full-Radius<br>Resector | 9246A |
| Linvatec Corporation | Full-Radius<br>Resector | 9247A |
| Linvatec Corporation | Gator® | 9260A |
| Linvatec Corporation | Gator® | 9263A |
| Linvatec Corporation | Full-Radius<br>Resector | C9241 |
| Linvatec Corporation | Full-Radius<br>Resector | C9245 |
| Linvatec Corporation | Full-Radius<br>Resector | C9248 |
| Linvatec Corporation | Cuda® | C9253 |
| Linvatec Corporation | Cuda® | C9254 |
| Linvatec Corporation | Cuda® | C9255 |
| Linvatec Corporation | Cuda® | C9256 |
| Linvatec Corporation | Cuda® | C9258 |
| Linvatec Corporation | Gator® | C9262 |
| Manufacturer | Description | Model |
| Linvatec Corporation | Gator® | C9264 |
| Linvatec Corporation | Gator® | C9266 |
| Linvatec Corporation | Slotted Whisker | C9274 |
| Linvatec Corporation | Slotted Whisker | C9275 |
| Linvatec Corporation | End Cutter | C9283 |
| Linvatec Corporation | End Cutter | C9284 |
| Linvatec Corporation | Dragon® | C9291 |
| Linvatec Corporation | Dragon® | C9292 |
| Linvatec Corporation | Meniscus Cutter | C9760 |
| Linvatec Corporation | Merlin Cuda® | P9356 |
| Linvatec Corporation | Merlin Gator® | P9366 |
| Linvatec Corporation | Merlin Full-Radius<br>Resector | P9376 |
| Linvatec Corporation | Great White™ | 9299A |

| Predicate device(s): | |
|----------------------|----------------------------------------|
| K940515 | Linvatec® Merlin Polyblade Shavers |
| K971059 | Linvatec® Universal Drive System |
| K981269 | Linvatec® Universal Drive System |
| K981636 | Linvatec® Integrated Drive/Pump System |
| K990524 | Linvatec® E9000 System |

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Image /page/1/Picture/0 description: The image shows three curved black lines. The lines are parallel to each other and are arranged in a slightly arched formation. The lines appear to be thick and solid, with a smooth, uniform texture. The background is plain white, which contrasts with the black lines.

# A L L I A N C E
MEDICAL CORPORATION

| MEDICAL CORPORATION | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description: | Arthroscopic shavers can be used to abrade, cut and excise tissue and bone;<br>remove loose fragments; and shave away debris in arthroscopic surgeries, as well<br>as surgeries of the jaw and sinuses.<br><br>The arthroscopic shaver components reprocessed by Alliance Medical<br>Corporation include a burr or blade at the end of a long rod that rotates within a<br>long hollow stain- less steel housing. The housing has a window cut out on one<br>side of the distal end, allowing the burr to cut one structure while the adjacent<br>one is still protected by the housing on the opposite side of the burr or blade. This<br>system attaches to a motorized<br>handpiece that drives the internal burr or blade inside the outer housing and<br>provides suction to pull the cut tissue away from the surgical site. |
| Intended use: | Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone<br>found in articular body cavities during orthopedic, maxillofacial, hand, foot and<br>plastic surgery in patients requiring arthroscopic or orthopedic surgery. |
| Indications<br>statement: | Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical<br>procedures of the joints, jaw or sinuses where the cutting and removal of soft and<br>hard tissue or bone is needed in patients requiring orthopedic surgery. |
| Technological<br>characteristics: | The design, materials, and intended use of the Reprocessed Arthroscopic Shavers<br>are identical to the predicate devices. The mechanism of action of the<br>Reprocessed Arthroscopic Shaver is identical to the predicate devices in that the<br>same standard mechanical design, materials, shapes and sizes are utilized. There<br>are no changes to the claims, intended use, clinical applications, patient<br>population, performance specifications, or method of operation. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety<br>and effectiveness) of the Reprocessed Arthroscopic Shavers.<br><br>Biocompatibility Validation of reprocessing Functionality Test(s) |
| | Performance testing demonstrates that Reprocessed Arthroscopic Shavers<br>perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807<br>and based on the information provided in this premarket notification, Alliance<br>Medical Corporation concludes that the modified device (the Reprocessed<br>Arthroscopic Shaver) is safe, effective and substantially equivalent to the<br>predicate devices as described herein. |

.

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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 7 2001

Mr. Don Selvey Vice President, Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K012613

Trade/Device Name: Alliance Medical Reprocessed Linvatec® Arthroscopic Shavers Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Selvey:

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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Page 2 - Mr. Don Selvey

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and in you to ough finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific ad 1.0 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8659. Additionally, for questions on the promotion and advertising of Compliance at [phone] First of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Togulation childed, "Milordanaing of esponsibilities under the Act may be obtained from the Oiner general mistmation sturers, 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,

Susan Walker, MP

Image /page/3/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a letter or a unique mark. The symbol has a loop at the top and a line extending from the bottom left.

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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NOV 0 7 2001

## II. Indications for Use Statement

#### KO12613 510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Shavers

Indications for Use: Reprocessed Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

| Manufacturer | Description | Model | Manufacturer | Description | Model |
|----------------------|-------------------------|-------|-----------------------|--------------------------------|-------|
| Linvatec Corporation | Full-Radius<br>Resector | 9246A | Linvatec Corporation | Gator® | C9264 |
| Linvatec Corporation | Full-Radius<br>Resector | 9247A | Linvatec Corporation | Gator® | C9266 |
| Linvatec Corporation | Gator® | 9260A | Linvatec Corporation | Slotted Whisker | C9274 |
| Linvatec Corporation | Gator® | 9263A | Linvatec Corporation | Slotted Whisker | C9275 |
| Linvatec Corporation | Full-Radius<br>Resector | C9241 | Linvatec Corporation | End Cutter | C9283 |
| Linvatec Corporation | Full-Radius<br>Resector | C9245 | Linvatec Corporation | End Cutter | C9284 |
| Linvatec Corporation | Full-Radius<br>Resector | C9248 | Linvatec Corporation | Dragon® | C9291 |
| Linvatec Corporation | Cuda® | C9253 | Linvatec Corporation | Dragon® | C9292 |
| Linvatec Corporation | Cuda® | C9254 | Linvatec Corporation | Meniscus Cutter | C9760 |
| Linvatec Corporation | Cuda® | C9255 | Linvatec Corporation | Merlin Cuda® | P9356 |
| Linvatec Corporation | Cuda® | C9256 | Linvatec Corporation | Merlin Gator® | P9366 |
| Linvatec Corporation | Cuda® | C9258 | Linvatec Corporation | Merlin Full-Radius<br>Resector | P9376 |
| Linvatec Corporation | Gator® | C9262 | Linvatec Corporations | Great White™ | 9299A |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

(Division Sign-Off) Division of Gen-1. Restorative over-the-Counter Use __________________________________________________________________________________________________________________________ and Neurological evices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

CONFIDENTIAL

Alliance Medical Corporation Reprocessed Arthroscopic Shavers Traditional 510(k)

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