(86 days)
Not Found
No
The device description and summary of performance studies focus on mechanical function and reprocessing, with no mention of AI or ML.
No
Explanation: The device is used for surgical procedures to cut and remove tissue and bone, which are direct interventions rather than therapeutic treatments.
No
Explanation: The device description states that the arthroscopic shaver is used for cutting and removing tissue and bone during surgical procedures, which is a therapeutic 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is an "Arthroscopic Shaver" used in surgical procedures to "cut and remove soft and hard tissue or bone." This is a surgical instrument used directly on the patient's body during a procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "orthopedic surgical procedures," which are invasive procedures performed on the patient.
Therefore, the function and intended use of this device fall under the category of a surgical instrument, not 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 Functionality 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.
K940515, K971059, K981269, K981636, K990524
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.
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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 company name. The lines are thick and black, and they are arranged in a semi-circular shape. The text "ALLIANCE MEDICAL CORPORATION" is written in a serif font.
Kola 613
PART B: 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 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 10, 2001 |
| Name of device: | Trade/Proprietary Name: Reprocessed Arthroscopic Shavers
Common or Usual Name: Arthroscopic Shaver
Classification Name: Arthroscope |
Reprocessed devices:
| Manufacturer | Description | Model |
|---|---|---|
| Linvatec Corporation | Full-Radius | |
| Resector | 9246A | |
| Linvatec Corporation | Full-Radius | |
| Resector | 9247A | |
| Linvatec Corporation | Gator® | 9260A |
| Linvatec Corporation | Gator® | 9263A |
| Linvatec Corporation | Full-Radius | |
| Resector | C9241 | |
| Linvatec Corporation | Full-Radius | |
| Resector | C9245 | |
| Linvatec Corporation | Full-Radius | |
| Resector | C9248 | |
| Linvatec Corporation | Cuda® | C9253 |
| Linvatec Corporation | Cuda® | C9254 |
| Linvatec Corporation | Cuda® | C9255 |
| Linvatec Corporation | Cuda® | C9256 |
| Linvatec Corporation | Cuda® | C9258 |
| Linvatec Corporation | Gator® | C9262 |
| Manufacturer | Description | Model |
| Linvatec Corporation | Gator® | C9264 |
| Linvatec Corporation | Gator® | C9266 |
| Linvatec Corporation | Slotted Whisker | C9274 |
| Linvatec Corporation | Slotted Whisker | C9275 |
| Linvatec Corporation | End Cutter | C9283 |
| Linvatec Corporation | End Cutter | C9284 |
| Linvatec Corporation | Dragon® | C9291 |
| Linvatec Corporation | Dragon® | C9292 |
| Linvatec Corporation | Meniscus Cutter | C9760 |
| Linvatec Corporation | Merlin Cuda® | P9356 |
| Linvatec Corporation | Merlin Gator® | P9366 |
| Linvatec Corporation | Merlin Full-Radius | |
| Resector | P9376 | |
| Linvatec Corporation | Great White™ | 9299A |
| Predicate device(s): | |
|---|---|
| K940515 | Linvatec® Merlin Polyblade Shavers |
| K971059 | Linvatec® Universal Drive System |
| K981269 | Linvatec® Universal Drive System |
| K981636 | Linvatec® Integrated Drive/Pump System |
| K990524 | Linvatec® E9000 System |
Antonio Station Market Particle Particle Property Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come
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Image /page/1/Picture/0 description: The image shows three curved black lines. The lines are parallel to each other and are arranged in a slightly arched formation. The lines appear to be thick and solid, with a smooth, uniform texture. The background is plain white, which contrasts with the black lines.
A L L I A N C E
MEDICAL CORPORATION
| MEDICAL CORPORATION | |
|---|---|
| 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 Functionality 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. |
.
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.
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: K012613
Trade/Device Name: Alliance Medical Reprocessed Linvatec® 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) I mis icter will and in you to ough finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific ad 1.0 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8659. Additionally, for questions on the promotion and advertising of Compliance at (301) 597-1697 First of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Togulation childed, "Milordanaing of esponsibilities under the Act may be obtained from the Oiner general mistmation sturers, 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, MP
Image /page/3/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a stylized or cursive form, possibly resembling a letter or a unique mark. The symbol has a loop at the top and a line extending from the bottom left.
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
4
NOV 0 7 2001
II. Indications for Use Statement
KO12613 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 | Model | Manufacturer | Description | Model |
|---|---|---|---|---|---|
| Linvatec Corporation | Full-Radius | ||||
| Resector | 9246A | Linvatec Corporation | Gator® | C9264 | |
| Linvatec Corporation | Full-Radius | ||||
| Resector | 9247A | Linvatec Corporation | Gator® | C9266 | |
| Linvatec Corporation | Gator® | 9260A | Linvatec Corporation | Slotted Whisker | C9274 |
| Linvatec Corporation | Gator® | 9263A | Linvatec Corporation | Slotted Whisker | C9275 |
| Linvatec Corporation | Full-Radius | ||||
| Resector | C9241 | Linvatec Corporation | End Cutter | C9283 | |
| Linvatec Corporation | Full-Radius | ||||
| Resector | C9245 | Linvatec Corporation | End Cutter | C9284 | |
| Linvatec Corporation | Full-Radius | ||||
| Resector | C9248 | Linvatec Corporation | Dragon® | C9291 | |
| Linvatec Corporation | Cuda® | C9253 | Linvatec Corporation | Dragon® | C9292 |
| Linvatec Corporation | Cuda® | C9254 | Linvatec Corporation | Meniscus Cutter | C9760 |
| Linvatec Corporation | Cuda® | C9255 | Linvatec Corporation | Merlin Cuda® | P9356 |
| Linvatec Corporation | Cuda® | C9256 | Linvatec Corporation | Merlin Gator® | P9366 |
| Linvatec Corporation | Cuda® | C9258 | Linvatec Corporation | Merlin Full-Radius | |
| Resector | P9376 | ||||
| Linvatec Corporation | Gator® | C9262 | Linvatec Corporations | Great White™ | 9299A |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
(Division Sign-Off) Division of Gen-1. Restorative over-the-Counter Use __________________________________________________________________________________________________________________________ and Neurological evices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Arthroscopic Shavers Traditional 510(k)
12