(86 days)
Not Found
No
The description focuses on the mechanical function of a reprocessed surgical tool and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as an arthroscopic shaver used for cutting and removing tissue and bone during orthopedic surgical procedures, which are interventional actions rather than therapeutic.
No
Explanation: The device description clearly states its function is for cutting and removing tissue and bone in surgical procedures, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a bur or blade, housing, and a motorized handpiece, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the arthroscopic shavers are used during surgical procedures to cut and remove tissue and bone within the body. They are surgical instruments, not devices that analyze samples outside the body.
- Intended Use: The intended use is for orthopedic surgical procedures, which are performed directly on the patient's body.
The information provided describes a surgical tool used for mechanical manipulation of tissue and bone during surgery, which is the opposite of an in vitro diagnostic device.
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
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 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.
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
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
Not Found
Predicate Device(s)
K833587, K904284, K934229, K953096, K953695, K771218, K820367, K971253, K900070
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Street
Phoenix, Arizona 85044 | |
|----------------------|------------------------------------------------------------------------------------------|--|
| Contact: | Don Selvey
Vice 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
1
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 | | | | | |
.
2
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
.
| 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. |
:
3
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.
4
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
5
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