(86 days)
Not Found
No
The document describes a mechanical surgical device and its reprocessing, with no mention of AI or ML in the description, intended use, or performance studies.
No.
The device description indicates that it is used for cutting and removing tissue and bone during surgery, which is a surgical tool, not a therapeutic device.
No
The device description clearly states its function is to "abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries". This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly outlines physical components like a burr, blade, housing, and a motorized handpiece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that the Reprocessed Arthroscopic Shavers are used during surgical procedures to cut and remove tissue and bone within the body. This is an invasive surgical tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for orthopedic surgical procedures, not for analyzing biological samples for diagnostic purposes.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular body cavities, joints, jaw, sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Shavers perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Corporation
10232 South 51st Street
Phoenix, Arizona 85044 | | |
|----------------------|------------------------------------------------------------------------------------------|-------------------------------------|--|
| Contact: | Don Selvey
Vice President, Regulatory Affairs and Quality Assurance
(480) 763-5300 | | |
| Date of preparation: | August 11, 2001 | | |
| Name of device: | Trade/Proprietary Name: | Reprocessed Arthroscopic
Shavers | |
| | 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
| Predicate
device(s): | K963332
K973195
K982375 | Stryker® Thermo-Plastic Shaver Blades
Stryker® Total Performance System Shaver Handpiece
Stryker®, Stryker Hip Arthroscopy Set |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. | |
| 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
Shavers are identical to the predicate devices. The mechanism of action of
the Reprocessed Arthroscopic Shaver 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 Shavers.
Biocompatibility Validation of reprocessing Function Test(s)
Performance testing demonstrates that Reprocessed Arthroscopic Shavers
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 Shaver) is safe, effective and substantially
equivalent 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 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 |
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)