(86 days)
The 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 away from the surgical site.
The provided text describes the 510(k) summary for "Reprocessed Arthroscopic Shavers" by Alliance Medical Corporation. This pertains to the reprocessing of existing medical devices, not a new device with its own specific performance criteria derived from a study comparing it to an AI or human system.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. This document focuses on demonstrating substantial equivalence to predicate devices for reprocessed medical instruments.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." However, it does not provide specific quantitative acceptance criteria or detailed reported performance metrics (e.g., cutting force, sharpness retention, etc.) for the reprocessed devices. The acceptance criteria described are largely qualitative, focusing on equivalence to the original devices and successful reprocessing.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a study evaluating a diagnostic or AI device with a test set of data. The "test set" in this context refers to the reprocessed devices themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. Ground truth as typically understood for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the reprocessed devices is that they perform as originally intended, which would be validated through engineering and functional testing.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This is not an AI-assisted diagnostic or classification device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a reprocessed physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used:
For the reprocessed devices, the "ground truth" is that they retain the performance characteristics (e.g., physical dimensions, material integrity, sharpness, cutting efficiency) and safety profiles of the original, new devices. This would be established through a combination of:
- Biocompatibility Validation: Ensuring no harmful residuals or material degradation from reprocessing.
- Reprocessing Function Test(s): Verifying the effectiveness of sterilization and cleaning protocols.
- Performance Testing: Bench and laboratory testing to confirm that the reprocessed shavers perform equivalently to new shavers as "originally intended." This likely involves mechanical testing, cutting force measurements, and visual inspection for integrity.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of available information regarding acceptance criteria and "study":
-
Acceptance Criteria (Implicit):
- Substantial Equivalence: The reprocessed devices must be substantially equivalent to the predicate (original, new) devices in terms of design, materials, intended use, mechanism of action, performance specifications, and safety.
- Biocompatibility: The reprocessing process must ensure the device remains biocompatible.
- Functional Performance: The reprocessed device must "perform as originally intended," implying retained cutting ability, structural integrity, and proper function.
- Sterility: The reprocessing must achieve appropriate sterility.
-
Study/Evidence Provided:
- "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."
The document generally asserts equivalence and adequate testing without providing granular details about the specific tests performed, the quantitative acceptance thresholds, or the exact results of those tests. This level of detail is typical for a 510(k) summary for reprocessed devices, where the focus is often on demonstrating that the reprocessing does not alter the fundamental characteristics or performance of the device relative to its original, legally marketed form.
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NOV 0 7 2001
Submitter:
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 way that suggests movement or progress. The text "ALLIANCE MEDICAL CORPORATION" is written in a simple, sans-serif font.
510(k) Summary of Safety and Effectiveness
10232 South 51st Street Phoenix, Arizona 85044
TEL 480.763.5300
FAX 480.763.5310
Toll Free 888.888.3433
Toll Free 888.888.3433 -medical.com
| Submitter: | 10232 South 51st StreetPhoenix, Arizona 85044 | |
|---|---|---|
| Contact: | Don SelveyVice President, Regulatory Affairs and Quality Assurance(480) 763-5300 | |
| Date of preparation: | 10 August 2001 | |
| Name of device: | Reprocessed Arthroscopic Shavers | |
| Common Name: | Arthroscopic Shaver | |
| Classification Name: | Arthroscope |
Alliance Medical Corporation
Reprocessed device(s):
| Manufacturer | Description | Model |
|---|---|---|
| Dyonics® | Cutter | 3439 |
| Dyonics® | Cutter | 3440 |
| Dyonics® | Trimmer | 3441 |
| Dyonics® | Full Radius | 3442 |
| Dyonics® | Full Radius | 3443 |
| Dyonics® | Full Radius | 3444 |
| Dyonics® | Turbo Whisker | 3446 |
| Dyonics® | Turbo Trimmer | 3529 |
| Dyonics® | Incisor | 3810 |
| Dyonics® | Synovator | 3826 |
| Dyonics® | Synovator | 4190 |
| Dyonics® | Incisor | 4191 |
| Dyonics® | Razor Cut | 4222 |
| Dyonics® | Incisor | 4223 |
| Dyonics® | Razor Cut | 4280 |
| Dyonics® | Razor Cut | 4284 |
| Dyonics® | Full Radius | 7205305 |
| Dyonics® | Full Radius | 7205306 |
| Dyonics® | Full Radius | 7205307 |
| Dyonics® | Cutter | 7205308 |
| Dyonics® | Cutter | 7205309 |
| Dyonics® | Synovator | 7205310 |
| Dyonics® | Synovator | 7205311 |
| Dyonics® | Incisor | 7205312 |
| Dyonics® | Incisor | 7205313 |
| Dyonics® | Incisor | 7205314 |
The starter of the
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Image /page/1/Picture/0 description: The image shows three curved lines that are stacked on top of each other. The lines are thick and black, and they appear to be slightly blurred. The lines are arranged in a way that creates a sense of movement or flow. The background of the image is white.
A L L I A N C E
MEDICAL CORPORATION
| Dyonics® | Turbo Trimmer | 7205315 |
|---|---|---|
| Dyonics® | Turbo Whisker | 7205316 |
| Dyonics® | Razorcut | 7205317 |
| Dyonics® | Razorcut | 7205318 |
| Dyonics® | Razorcut | 7205319 |
| Dyonics® | Incisor | 7205345 |
| Dyonics® | Incisor | 7205459 |
| 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 | |||||
| K820367 | Smith & Nephew Dyonics® Intra-Articular Surgical System | |||||
| K971253 | Smith & Nephew Dyonics® Endoscopic Surgery Blades | |||||
| K900070 | 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 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 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 |
.
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Image /page/2/Picture/0 description: The image shows a logo with three curved lines above the word "ALLIANCE". The three lines are arranged in a parallel fashion, with each line curving upwards and to the right, resembling a stylized representation of motion or energy. The word "ALLIANCE" is written in a bold, sans-serif font, positioned directly below the curved lines, suggesting that the lines are a symbol associated with the organization or entity named "ALLIANCE".
ALLIANCE MEDICAL CORPORATION
.
| Indicationsstatement: | Reprocessed arthroscopic shavers are indicated for use inorthopedic surgical procedures of the joints, jaw or sinuses wherethe cutting and removal of soft and hard tissue or bone is needed inpatients requiring orthopedic surgery. |
|---|---|
| Technologicalcharacteristics: | The design, materials, and intended use of the ReprocessedArthroscopic Shavers are identical to the predicate devices. Themechanism of action of the Reprocessed Arthroscopic Shaver isidentical to the predicate devices in that the same standardmechanical design, materials, shapes and sizes are utilized. Thereare no changes to the claims, intended use, clinical applications,patient population, performance specifications, or method ofoperation. |
| Performancedata: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the ReprocessedArthroscopic Shavers.Biocompatibility Validation of reprocessing Function test(s)Performance testing demonstrates that Reprocessed ArthroscopicShavers perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21CFR Part 807 and based on the information provided in thispremarket notification, Alliance Medical Corporation concludesthat the modified device (the Reprocessed Arthroscopic Shaver) issafe, effective and substantially equivalent to the predicate devicesas described herein. |
:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.
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: K012611
Trade/Device Name: Alliance Medical Reprocessed Dyonics® 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.
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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,
Susan Welker, us
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 7 2001
INDICATIONS FOR USE
K DI2611 510(k) Number:
Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Shavers
Indications for Use: The 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 | Manufacturer | Description |
|---|---|---|---|---|
| Dyonics | Cutter | 3439 | Dyonics | Full Radius |
| Dyonics | Cutter | 3440 | Dyonics | Full Radius |
| Dyonics | Trimmer | 3441 | Dyonics | Cutter |
| Dyonics | Full Radius | 3442 | Dyonics | Cutter |
| Dyonics | Full Radius | 3443 | Dyonics | Synovator |
| Dyonics | Full Radius | 3444 | Dyonics | Synovator |
| Dyonics | Turbo Whisker | 3446 | Dyonics | Incisor |
| Dyonics | Turbo Trimmer | 3529 | Dyonics | Incisor |
| Dyonics | Incisor | 3810 | Dyonics | Incisor |
| Dyonics | Synovator | 3826 | Dyonics | Turbo Trimmer |
| Dyonics | Synovator | 4190 | Dyonics | Turbo Whisker |
| Dyonics | Incisor | 4191 | Dyonics | Razorcut |
| Dyonics | Razor Cut | 4222 | Dyonics | Razorcut |
| Dyonics | Incisor | 4223 | Dyonics | Razorcut |
| Dyonics | Razor Cut | 4280 | Dyonics | Orbit Synovator |
| Dyonics | Razor Cut | 4284 | Dyonics | Incisor |
| Dyonics | Full Radius | 7205305 | Dyonics | Incisor |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
Lisa Wal
(Division Sign-Off) Division of General, Restorative and Neurological Jevices
510(k) Number K612614
Model
7205306
7205311
7205316
7205317 7205318 7205319
7205321 7205345 7205459
§ 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.