(88 days)
Reprocessed Arthroscopic Shavers are intended to resect 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 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 bur or blade at the end of a long rod that rotates within a long hollow stainless 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 or 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 and/or bone away from the surgical site.
The provided document is limited in detail regarding specific acceptance criteria and the studies conducted. It primarily focuses on demonstrating substantial equivalence of reprocessed arthroscopic burs to predicate devices. Here's a breakdown of the information that can be extracted, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance (Safety & Effectiveness) | "Performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended." |
| Biocompatibility | Explicitly stated as conducted. No specific quantitative criteria or results are provided. |
| Validation of Reprocessing | Explicitly stated as conducted. No specific quantitative criteria or results are provided. |
| Function Test(s) | Explicitly stated as conducted. No specific quantitative criteria or results are provided. |
| Design, Materials, Intended Use | "The design, materials, and intended use of the Reprocessed Arthroscopic Burs are identical to the predicate devices." |
| Mechanism of Action | "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." |
| Changes to Claims, Intended Use, Clinical Applications, Patient Population, Performance Specifications, Method of Operation | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench and laboratory testing was conducted," but it does not specify the sample size for any of these tests. It also does not provide information on data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not available in the provided document. The studies were described as "Bench and laboratory testing," which typically does not involve human expert adjudication in the same way clinical studies would.
4. Adjudication Method for the Test Set
This information is not applicable/not available as the studies described are bench and laboratory tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies conducted were "Bench and laboratory testing" focused on the performance of the reprocessed burs themselves, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is an arthroscopic bur, a physical surgical tool, not an
AI algorithm. Therefore, there is no "algorithm-only" performance to assess.
7. The Type of Ground Truth Used
The ground truth for the "Bench and laboratory testing" would have been established by engineering and quality control standards for medical device performance. For example:
- Biocompatibility: Likely relies on standardized tests showing no adverse biological reactions.
- Reprocessing Validation: Involves demonstrating the sterilization and cleanliness of the reprocessed device meets required standards.
- Function Tests: Involves objective measurements of the device's cutting ability, rotational speed, durability, etc., against predefined specifications derived from new devices or industry standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a reprocessed physical medical tool, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
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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 word "ALLIANCE" in capital letters. Below the word "ALLIANCE" is the phrase "MEDICAL CORPORATION" in smaller capital letters. The logo is black and white.
NOV 0 9 2001
PART B: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
10232 South 5 1st Street Phoenix, Arizona 85044
TEL 480.763.5300 FAX 480.763.5310 Toll Free 888.888.3433 ww.alliance-medical.com
Submitter:
Alliance Medical Corporation 10232 South 51st Street Phoeniz, Arizona 85044
Contact:
Don Selvev 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 |
|---|---|---|
| Linvatec Corporation | Oval Bur | C9101 |
| Linvatec Corporation | Oval Bur | C9102 |
| Linvatec Corporation | Oval Bur Left Helix | C9106 |
| Linvatec Corporation | Spherical Bur | C9110 |
| Linvatec Corporation | Spherical Bur | C9111 |
| Linvatec Corporation | Spherical Bur | C9112 |
| Linvatec Corporation | Vortex Router | C9131 |
| Linvatec Corporation | Vortex Router Unhooded | C9134 |
| Linvatec Corporation | Oval Bur | H9101 |
| Linvatec Corporation | Oval Bur | H9102 |
| Linvatec Corporation | Spherical Bur | H9110 |
| Linvatec Corporation | Vortex Router Hooder | H9131 |
| Linvatec Corporation | Vortex Router | H9132 |
Predicate device(s):
K940515 K971059 K981269 K981636 K990524
Linvatec® Merlin Polyblade Shavers Linvatec® Universal Drive System Linvatec® Universal Drive System Linvatec® Integrated Drive/Pump System Linvatec® E9000 System
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 stainless steel housing.
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KOi 2630
Image /page/1/Picture/1 description: The image shows three curved lines that are stacked on top of each other. The lines are black and have a thick, bold appearance. The lines are arranged in a way that creates a sense of depth and movement. The overall impression is one of simplicity and elegance.
ALLIANCE MEDICAL CORPORATION
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 or 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 and/or bone away from the surgical site.
Reprocessed Arthroscopic Shavers are intended to resect 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 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.
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.
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.
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.
Intended use:
Indications statement:
Technological characteristics:
Performance data:
Conclusion:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2001
Mr. Don Selvey Regulatory Affairs and Quality Assurance Alliance Medical Corporation, Inc. 10232 South 51st Street Phoenix, Arizona 85044
Re: K012630
Trade/Device Name: Reprocessed Linvatec 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 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) 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,
Styph Rhodes
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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II. Indications for Use Statement
NOV 0 9 2001
KO12630 510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed [device name]
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 |
|---|---|---|
| Linvatec Corporation | Oval Bur | C9101 |
| Linvatec Corporation | Oval Bur | C9102 |
| Linvatec Corporation | Oval Bur Left Helix | C9106 |
| Linvatec Corporation | Spherical Bur | C9110 |
| Linvatec Corporation | Spherical Bur | C9111 |
| Linvatec Corporation | Spherical Bur | C9112 |
| Linvatec Corporation | Vortex Router | C9131 |
| Linvatec Corporation | Vortex Router Unhooded | C9134 |
| Linvatec Corporation | Oval Bur | H9101 |
| Linvatec Corporation | Oval Bur | H9102 |
| Linvatec Corporation | Spherical Bur | H9110 |
| Linvatec Corporation | Vortex Router Hooder | H9131 |
| Linvatec Corporation | Vortex Router | H9132 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styck Rurder
Prescription Use (per 21 CFR 801.109)
CONFIDENTIAL
Sign-Off) Division of General, Restorativer-the-Counter Use ____________________________________________________________________________________________________________________________ and Neurological Devices
510(k) Number
Alliance Medical Corporation
Reprocessed Arthroscopic Burs
Traditional 510(k)
12
§ 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.