Who is the manufacturer of REPROCESSED DYONICS ARTHROSCOPIC BURS?

Alliance Medical Corp. filed the 510(k) submission for REPROCESSED DYONICS ARTHROSCOPIC BURS (K012652).

What is the FDA product code for REPROCESSED DYONICS ARTHROSCOPIC BURS?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for REPROCESSED DYONICS ARTHROSCOPIC BURS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for REPROCESSED DYONICS ARTHROSCOPIC BURS?

Smith & Nephew Dyonics® Disposable Arthorscopy Blade (K833587); Smith & Nephew Dyonics® Arthroscopic Surgical Blade (K904284); Smith & Nephew Dyonics® Disposable Arthroscopic Surgery Blades (K934229); Smith & Nephew Dyonics® EP-1 Shaver (K953096); Smith & Nephew Dyonics® Disposable Arthroscopic Blades (K953695); Smith & Nephew Dyonics® Intra-Articular Shaver (K771218).

Who can help prepare an FDA 510(k) submission like REPROCESSED DYONICS ARTHROSCOPIC BURS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REPROCESSED DYONICS ARTHROSCOPIC BURS

K012652 · Alliance Medical Corp. · HRX · Nov 8, 2001 · Orthopedic

Device Facts

Record ID	K012652
Device Name	REPROCESSED DYONICS ARTHROSCOPIC BURS
Applicant	Alliance Medical Corp.
Product Code	HRX · Orthopedic
Decision Date	Nov 8, 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 burs/shavers consist of a bur or blade at the end of a long rod rotating within a hollow stainless steel housing. The housing features a distal window allowing the bur to cut target tissue while protecting adjacent structures. The device attaches to a motorized handpiece that drives the internal blade and provides suction to remove cut tissue from the surgical site. Used in orthopedic, maxillofacial, hand, foot, and plastic surgeries; operated by surgeons in clinical settings. The device functions by mechanical abrasion, cutting, and excision of tissue and bone. Reprocessing restores the device to original performance specifications, providing a cost-effective alternative to new disposable blades.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, validation of the reprocessing protocol, and functional performance testing to ensure the reprocessed burs meet original manufacturer specifications.

Technological Characteristics

Stainless steel housing with internal rotating bur/blade. Mechanical actuation via motorized handpiece. Suction-assisted tissue removal. Design, materials, and dimensions are identical to original predicate devices.

Indications for Use

Indicated for orthopedic surgical procedures of the joints, jaw, or sinuses requiring cutting and removal of soft and hard tissue or bone 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

Smith & Nephew Dyonics® Disposable Arthorscopy Blade (K833587)
Smith & Nephew Dyonics® Arthroscopic Surgical Blade (K904284)
Smith & Nephew Dyonics® Disposable Arthroscopic Surgery Blades (K934229)
Smith & Nephew Dyonics® EP-1 Shaver (K953096)
Smith & Nephew Dyonics® Disposable Arthroscopic Blades (K953695)
Smith & Nephew Dyonics® Intra-Articular Shaver (K771218)

Reference Devices

Smith & Nephew Dyonics® Intra-Articular Surgical System (K820367)
Smith & Nephew Dyonics® Endoscopic Surgery Blades (K971253)
Smith & Nephew Dyonics® Modified Uses of the Arthroscopic Surgical System, Trimmer Blade and Full Radius Blade (K900070)

Related Devices

K012613 — REPROCSSED LINVATEC SHAVERS · Alliance Medical, Inc. · Nov 7, 2001
K012611 — REPROCESSED DYONICS ARTHROSCOPIC SHAVERS · Alliance Medical, Inc. · Nov 7, 2001
K012630 — REPROCESSED LINVATEC ARTHROSCOPIC BURS · Alliance Medical, Inc. · Nov 9, 2001
K012635 — REPROCESSED STRYKER ARTHROSCOPIC SHAVERS · Alliance Medical Corp. · Nov 7, 2001
K172092 — Reprocessed Shavers/Burs · Renovo, Inc. · Oct 4, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ ## PART B: 510(k) SUMMARY OF SAFETY # AND EFFECTIVENESS KO12652 ### NOV 0 82001 | Submitter: | Alliance Medical Corporation 10232 South 51st Street Phoeniz, Arizona 85044 | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Don Selvey Vice President, Regulatory Affairs and Quality Assurance (480) 763-5300 | | Date of preparation: | August 10, 2001 | | Name of device: | Trade/Proprietary Name: Reprocessed Arthroscopic Burs Common or Usual Name: Arthroscopic Bur Classification Name: Arthroscope | #### Reprocessed devices: | Manufacturer | Description | Model | |--------------|----------------------|---------| | Dyonics® | Abrader | 3450 | | Dyonics® | Abrader | 3451 | | Dyonics® | Acromionizer | 3452 | | Dyonics® | Acromionizer | 3453 | | Dyonics® | Stonecutter | 4304 | | Dyonics® | Stonecutter | 4305 | | Dyonics® | Notchblaster | 4306 | | Dyonics® | Notchblaster | 4307 | | Dyonics® | Abrader | 7205324 | | Dyonics® | Abrader | 7205325 | | Dyonics® | Acromionizer | 7205326 | | Dyonics® | Notchblaster Abrader | 7205328 | | Dyonics® | Notchblaster | 7205329 | | Dyonics® | Stone Cutter | 7205330 | | Dyonics® | Acromioblaster | 7205668 | | Dyonics® | Acromioblaster | 7205669 | | Dyonics® | Helicut Bur | 7205727 | | Predicate device(s): | | | |-------------------------|---------|----------------------------------------------------------------| | | K833587 | Smith & Nephew Dyonics® Disposable Arthorscopy Blade | | | K904284 | Smith & Nephew Dyonics® Arthroscopic Surgical Blade | | | K934229 | Smith & Nephew Dyonics® Disposable Arthroscopic Surgery Blades | | | K953096 | Smith & Nephew Dyonics® EP-1 Shaver | | | K953695 | Smith & Nephew Dyonics® Disposable Arthroscopic Blades | | | K771218 | Smith & Nephew Dyonics® Intra-Articular Shaver | {1}------------------------------------------------ K012652 | K820367 K971253 K900070 | Smith & Nephew Dyonics® Intra-Articular Surgical System Smith & Nephew Dyonics® Endoscopic Surgery Blades Smith & Nephew Dyonics® Modified Uses of the Arthroscopic Surgical System, Trimmer Blade and Full Radius Blade | | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Device description: | Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. | | | | The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a Bur or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the Bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur on blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site | | | 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. | | | Indications statement: | 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. | | | Technological characteristics: | The design, materials, and intended use of the Reprocessed Arthroscopic Burs are identical to the predicate devices. The mechanism of action of the Reprocessed Arthroscopic Bur is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. | | | Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Burs. ● Biocompatibility ● Validation of reprocessing ● Function Test(s) | | | | Performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended. | | | Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed Arthroscopic Bur) is safe, effective and substantially equivalent to the predicate devices as described herein. | | .............................................................................................................................................................................. : : {2}------------------------------------------------ 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized bird with three wing-like shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 82001 Mr. Don Selvey Vice President, Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044 Re: K012652 Trade/Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Burs Regulation Number: 888.1100 Regulation Name: Arthroscope 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 we nave roviewed your becaused on (d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are may 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to rial to rial) 2011-07-11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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. {3}------------------------------------------------ #### Page 2 - Mr. Don Selvey This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter will and n yourse 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far & 659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Walker, MD Image /page/3/Picture/5 description: The image shows a close-up of a handwritten signature. The signature is in black ink and appears to be cursive. The signature is illegible, but it has a loop at the top and a flourish at the end. 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 {4}------------------------------------------------ NOV 0 82001 KDI2652 ## 2. Indications for Use Statement 510(k) Number (if known): K012652 Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Burs Indications for Use: Reprocessed Arthroscopic Burs 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. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (per 21 CFR 801.109) f Susan Wall Over-the-Counter Use (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number #k012652 CONFIDENTIAL Alliance Medical Corporation Reprocessed Arthroscopic Burs Traditional 510(k)