(87 days)
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.
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.
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
The provided document K012652 is a 510(k) summary for "Reprocessed Arthroscopic Burs" and does not describe an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance typical for AI/ML devices, such as those involving sensitivity, specificity, or human expert performance.
Specifically, the document focuses on demonstrating substantial equivalence of reprocessed medical devices to predicate devices. The performance data mentioned relates to:
- Biocompatibility
- Validation of reprocessing
- Function Test(s)
The conclusion states that performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended, implying that they meet the same performance standards as new, unreprocessed devices, which are the predicate devices.
Since this is not an AI/ML device submission, the requested information elements such as a table of acceptance criteria vs. reported AI performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable and are not present in the provided text.
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PART B: 510(k) SUMMARY OF SAFETY
AND EFFECTIVENESS KO12652
NOV 0 82001
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoeniz, Arizona 85044 |
|---|---|
| Contact: | Don SelveyVice President, Regulatory Affairs and Quality Assurance(480) 763-5300 |
| Date ofpreparation: | August 10, 2001 |
| Name of device: | Trade/Proprietary Name: Reprocessed Arthroscopic BursCommon or Usual Name: Arthroscopic BurClassification 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 |
| Predicatedevice(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 |
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| K820367K971253K900070 | Smith & Nephew Dyonics® Intra-Articular Surgical SystemSmith & Nephew Dyonics® Endoscopic Surgery BladesSmith & Nephew Dyonics® Modified Uses of theArthroscopic 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, aswell as surgeries of the jaw and sinuses. | |
| The arthroscopic shaver components reprocessed by Alliance MedicalCorporation include a Bur or blade at the end of a long rod that rotates withina long hollow stain- less steel housing. The housing has a window cut out onone side of the distal end, allowing the Bur to cut one structure while theadjacent one is still protected by the housing on the opposite side of the bur onblade. This system attaches to a motorized handpiece that drives the internalbur or blade inside the outer housing and provides suction to pull the cuttissue away from the surgical site | ||
| Intended use: | Reprocessed Arthroscopic Shavers are intended for resecting tissue and bonefound in articular body cavities during orthopedic, maxillofacial, hand, footand plastic surgery in patients requiring arthroscopic or orthopedic surgery. | |
| Indications statement: | Reprocessed arthroscopic shavers are indicated for use in orthopedic surgicalprocedures of the joints, jaw or sinuses where the cutting and removal of softand hard tissue or bone is needed in patients requiring orthopedic surgery. | |
| Technological characteristics: | The design, materials, and intended use of the Reprocessed ArthroscopicBurs are identical to the predicate devices. The mechanism of action of theReprocessed Arthroscopic Bur is identical to the predicate devices in that thesame standard mechanical design, materials, shapes and sizes are utilized.There are no changes to the claims, intended use, clinical applications, patientpopulation, 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 Bursperform as originally intended. | ||
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part807 and based on the information provided in this premarket notification,Alliance Medical Corporation concludes that the modified device (theReprocessed Arthroscopic Bur) is safe, effective and substantially equivalentto the predicate devices as described herein. |
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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.
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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 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
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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)
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.