(86 days)
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.
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 burr 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 burr to cut one structure while the adjacent one is still protected by the housing on the opposite side of the burr or blade. This system attaches to a motorized handpiece that drives the internal burr or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site.
The provided text describes a 510(k) premarket notification for "Reprocessed Arthroscopic Shavers" by Alliance Medical Corporation. It addresses the substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics. The performance data section broadly mentions "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers." and a statement that "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." However, the document does not provide specific acceptance criteria or the detailed study results that prove the device meets these criteria.
Therefore, much of the requested information cannot be extracted from the provided text.
Here is a summary of what can be inferred or directly stated from the document, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (e.g., cutting efficiency, material integrity, sterility after reprocessing, fatigue resistance) | "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." (No specific metrics or data provided.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The testing was "Bench and laboratory testing." The country of origin is not specified, but the submitter is in Phoenix, Arizona, USA. It describes testing, which would imply prospective data collection for the validation of the reprocessed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The nature of the device (reprocessed surgical instruments) suggests that the "ground truth" would likely be based on engineering specifications and performance standards rather than expert clinical judgment in the same way an AI diagnostic tool would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the type of product, such a method would not typically be applicable; testing would involve quantifiable measurements against defined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a reprocessed medical device (arthroscopic shaver), not an AI diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- N/A. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth for the reprocessed shavers is their ability to "perform as originally intended," likely referring to the manufacturer's original specifications for new shavers. This would involve performance metrics such as cutting ability, structural integrity, and sterility. Specific details are not provided.
8. The sample size for the training set:
- N/A. This is a reprocessed medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- N/A. As above, a training set is not applicable to this type of device.
{0}------------------------------------------------
NOV 0 7 2001
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 slightly arched shape. The text "ALLIANCE MEDICAL CORPORATION" is written in a simple, sans-serif font.
PART B: 510(k) SUMMARY OF SAFETY ANQueenix, Arizon 8504 EFFECTIVENESS
TEL 480.763.5300
Toll Free 880.763.5310
Toll Free 888.888.3433
Toll Free 888.888.3433 www.alliance-medical.com
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 | ||
|---|---|---|---|
| Contact: | Don SelveyVice President, Regulatory Affairs and Quality Assurance(480) 763-5300 | ||
| Date of preparation: | August 11, 2001 | ||
| Name of device: | Trade/Proprietary Name: | Reprocessed ArthroscopicShavers | |
| Common or Usual Name: | Arthroscopic Shaver | ||
| Classification Name: | Arthroscope |
Reprocessed devices:
| Manufacturer | Description | Model | Manufacturer | Description | Model |
|---|---|---|---|---|---|
| Stryker | Jaguar Meniscus Cutter | 275-540 | Stryker | Whisker Cutter | 275-745 |
| Stryker | Cougar End Cutter | 275-541 | Stryker | Scallop Cutter | 275-746 |
| Stryker | Resector Cutter | 275-542 | Stryker | End Cutter | 275-747 |
| Stryker | Aggressive Plus Cutter | 275-544-000 | Stryker | Slotted Whisker | 275-748-000 |
| Stryker | Tomcat Cutter | 275-545-000 | Stryker | Full Radius | 275-752 |
| Stryker | Angled Tomcat Cutter | 275-545-100 | Stryker | Aggressive Meniscus-Cutter | 275-754-000 |
| Stryker | Cougar End Cutter | 275-551 | Stryker | Scalloped Cutter | 275-756-000 |
| Stryker | Resector Cutter | 275-552 | Stryker | End Cutter | 275-757 |
| Stryker | Resector Full Radius Cutter | 275-562-000 | Stryker | Slotted Whisker | 275-758 |
| Stryker | Aggressive Plus | 275-564-000 | Stryker | Angled Aggressive Meniscus | 280-744 |
| Stryker | Tomcat Cutter | 275-565-000 | Stryker | Angled Aggressive Meniscus | 280-754 |
| Stryker | Full Radius Cutter | 275-732-000 | Stryker | Full Radius | 275-762 |
| Stryker | Aggressive Meniscus Cutter | 275-734-000 | Stryker | Aggressive Meniscus Cutter | 275-764-000 |
| Stryker | End Cutter | 275-737 | Stryker | Scallop Cutter | 275-766 |
| Stryker | Full Radius | 275-742 | Stryker | Aggressive Meniscus Cutter | 277-744 |
| Stryker | Aggressive Meniscus Cutter | 275-744-000 | Stryker | True End Cutter | 275-884 |
ﻟﻤﺼﻨﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻌﻠﻰ
- 11:53 - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for Alliance. The logo consists of three curved lines stacked on top of each other, with the top line being the shortest and the bottom line being the longest. The lines are black and appear to be thick. Below the lines, the word "ALLIANCE" is written in capital letters.
:
A L L I A N C E
MEDICAL CORPORATION
| Predicatedevice(s): | K963332K973195K982375 | Stryker® Thermo-Plastic Shaver BladesStryker® Total Performance System Shaver HandpieceStryker®, Stryker Hip Arthroscopy Set |
|---|---|---|
| Devicedescription: | Arthroscopic shavers can be used to abrade, cut and excise tissue andbone; remove loose fragments; and shave away debris in arthroscopicsurgeries, as well as surgeries of the jaw and sinuses.The arthroscopic shaver components reprocessed by Alliance MedicalCorporation include a burr or blade at the end of a long rod that rotateswithin a long hollow stain- less steel housing. The housing has a windowcut out on one side of the distal end, allowing the burr to cut one structurewhile the adjacent one is still protected by the housing on the opposite sideof the burr or blade. This system attaches to a motorizedhandpiece that drives the internal burr or blade inside the outer housing andprovides suction to pull the cut tissue away from the surgical site. | |
| Intended use: | Reprocessed Arthroscopic Shavers are intended for resecting tissue andbone found in articular body cavities during orthopedic, maxillofacial, hand,foot and plastic surgery in patients requiring arthroscopic or orthopedicsurgery. | |
| Indicationsstatement: | Reprocessed arthroscopic shavers are indicated for use in orthopedicsurgical procedures of the joints, jaw or sinuses where the cutting andremoval of soft and hard tissue or bone is needed in patients requiringorthopedic surgery. | |
| Technologicalcharacteristics: | The design, materials, and intended use of the Reprocessed ArthroscopicShavers are identical to the predicate devices. The mechanism of action ofthe Reprocessed Arthroscopic Shaver is identical to the predicate devicesin that the same standard mechanical design, materials, shapes and sizesare utilized. There are no changes to the claims, intended use, clinicalapplications, patient population, performance specifications, or method ofoperation. | |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance(safety and effectiveness) of the Reprocessed Arthroscopic Shavers.Biocompatibility Validation of reprocessing Function Test(s)Performance testing demonstrates that Reprocessed Arthroscopic Shaversperform 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 Shaver) is safe, effective and substantiallyequivalent to the predicate devices as described herein. |
{2}------------------------------------------------
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
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: K012635
Trade/Device Name: Reprocessed Stryker® 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.
{3}------------------------------------------------
Page 2 - Mr. Don Selvey
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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 Compliance at (301) 594-4659. 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, up
Celia M. Witten, Ph.D., M.D. J Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
NOV 0 7 2001
II. Indications for Use Statement
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 Description | Model | . Manufacturer Description . Description . Model . | |||
|---|---|---|---|---|---|
| Stryker | Jaguar Meniscus Cutter | 275-540 | Stryker | Whisker Cutter | 275-745 |
| Stryker | Cougar End Cutter | 275-541 | Stryker | Scallop Cutter | 275-746 |
| Stryker | Resector Cutter | 275-542 | Stryker | End Cutter | 275-747 |
| Stryker | Aggressive Plus Cutter | 275-544-000 | Stryker | Slotted Whisker | 275-748-000 |
| Stryker | Tomcat Cutter | 275-545-000 | Stryker | Full Radius | 275-752 |
| Stryker | Angled Tomcat Cutter | 275-545-100 | Stryker | Aggressive Meniscus-Cutter | 275-754-000 |
| Stryker | Cougar End Cutter | 275-551 | Stryker | Scalloped Cutter | 275-756-000 |
| Stryker | Resector Cutter | 275-552 | Stryker | End Cutter | 275-757 |
| Stryker | Resector Full RadiusCutter | 275-562-000 | Stryker | Slotted Whisker | 275-758 |
| Stryker | Aggressive Plus | 275-564-000 | Stryker | Angled AggressiveMeniscus | 280-744 |
| Stryker | Tomcat Cutter | 275-565-000 | Stryker | Angled AggressiveMeniscus | 280-754 |
| Stryker | Full Radius Cutter | 275-732-000 | Stryker | Full Radius | 275-762 |
| Stryker | Aggressive MeniscusCutter | 275-734-000 | Stryker | Aggressive MeniscusCutter | 275-764-000 |
| Stryker | End Cutter | 275-737 | Stryker | Scallop Cutter | 275-766 |
| Stryker | Full Radius | 275-742 | Stryker | Aggressive MeniscusCutter | 277-744 |
| Stryker | Aggressive MeniscusCutter | 275-744-000 | Stryker | True End Cutter | 275-884 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) √
Susan Walker
(Division Sign Division of General, estorative and Neurological De ices 112635
510(k) Number Over-the-Counter Use
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Arthroscopic Shavers 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.