(87 days)
No
The device description and intended use describe a mechanical surgical tool for cutting and removing tissue and bone. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on biocompatibility, reprocessing validation, and function tests, which are typical for reprocessed mechanical devices.
No.
The device is used for cutting and removing tissue/bone during surgery; it is a surgical tool, not a therapeutic device designed to treat a condition.
No
The device description and intended use clearly state that arthroscopic shavers and burs are used for resecting tissue and bone, cutting, excising tissue, and removing loose fragments during surgery. These are interventional actions, not diagnostic ones.
No
The device description clearly outlines physical components like a bur or blade, a stainless steel 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:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for resecting tissue and bone during surgical procedures within the body. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical device with a cutting bur or blade used for physical removal of tissue and bone. This aligns with a surgical tool, not a diagnostic instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility, validation of reprocessing, and function tests, which are typical for surgical devices, not IVDs.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically remove tissue and bone during surgery, which is a therapeutic or procedural action, not a diagnostic one.
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 Burs 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 stain- less 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 on 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 (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 Burs.
Biocompatibility
Validation of reprocessing
Function Test(s)
Performance testing demonstrates that Reprocessed Arthroscopic Burs perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
PART B: 510(k) SUMMARY OF SAFETY
AND EFFECTIVENESS KO12652
NOV 0 82001
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoeniz, 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 Burs
Common or Usual Name: Arthroscopic Bur
Classification Name: Arthroscope |
Reprocessed devices:
| Manufacturer | Description | Model |
|---|---|---|
| Dyonics® | Abrader | 3450 |
| Dyonics® | Abrader | 3451 |
| Dyonics® | Acromionizer | 3452 |
| Dyonics® | Acromionizer | 3453 |
| Dyonics® | Stonecutter | 4304 |
| Dyonics® | Stonecutter | 4305 |
| Dyonics® | Notchblaster | 4306 |
| Dyonics® | Notchblaster | 4307 |
| Dyonics® | Abrader | 7205324 |
| Dyonics® | Abrader | 7205325 |
| Dyonics® | Acromionizer | 7205326 |
| Dyonics® | Notchblaster Abrader | 7205328 |
| Dyonics® | Notchblaster | 7205329 |
| Dyonics® | Stone Cutter | 7205330 |
| Dyonics® | Acromioblaster | 7205668 |
| Dyonics® | Acromioblaster | 7205669 |
| Dyonics® | Helicut Bur | 7205727 |
| 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 |
1
| K820367
K971253
K900070 | Smith & Nephew Dyonics® Intra-Articular Surgical System
Smith & Nephew Dyonics® Endoscopic Surgery Blades
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 stain- less 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 on
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. | |
| 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
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. | |
| Performance data: | 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. | |
| 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 Bur) is safe, effective and substantially equivalent
to the predicate devices as described herein. | |
..............................................................................................................................................................................
:
:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
Mr. Don Selvey Vice President, Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K012652
Trade/Device Name: Alliance Medical Corporation Reprocessed 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 we nave roviewed your becaused on (d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are may 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to rial to rial) 2011-07-11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 mb lotter will and n yourse 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 additionally 21 Of It Far & 659. 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, MD
Image /page/3/Picture/5 description: The image shows a close-up of a handwritten signature. The signature is in black ink and appears to be cursive. The signature is illegible, but it has a loop at the top and a flourish at the end.
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 82001
KDI2652
2. Indications for Use Statement
510(k) Number (if known): K012652
Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Burs
Indications for Use: Reprocessed Arthroscopic Burs 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
f Susan Wall Over-the-Counter Use
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number #K012652
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Arthroscopic Burs Traditional 510(k)