(86 days)
Not Found
No
The device description and performance studies focus on mechanical function and reprocessing validation, with no mention of AI or ML.
No
The device is described as an instrument for cutting and removing tissue during orthopedic surgical procedures, not as a device that treats a disease or condition itself.
No
The device is described as a surgical tool used for cutting and removing tissue/bone during orthopedic procedures, not for diagnosing conditions.
No
The device description clearly outlines physical components (bur, blade, rod, housing) and their mechanical function, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and removal of soft and hard tissue or bone... in orthopedic surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a mechanical device with a rotating bur or blade for cutting tissue. This is consistent with a surgical instrument, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of these samples.
Therefore, the Reprocessed Arthroscopic Burs are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Reprocessed Arthroscopic Burs 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 (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Arthroscopic Bur 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
patients requiring arthroscopic or orthopedic surgery, patients requiring orthopedic surgery.
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): 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
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "KOI2605". The characters are written in a casual, slightly slanted style, with varying stroke thicknesses.
Image /page/0/Picture/2 description: The image shows the logo for Alliance Medical Corporation. The logo consists of three curved lines above the company name. The lines are arranged in a parallel fashion, with each line slightly offset from the others. The text "ALLIANCE MEDICAL CORPORATION" is written in a serif font.
PART B: 510(k) SUMMARY OF SAFETY phoenix, Arizon 85044
AND EFFECTIVENESS
TEL 480.763.5300
FAX 480.763.5310 Toll Free 888.888.3433 www.alliance-medical.com
ಿ ಸ
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| 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 Athroscopics Burs
Common or Usual Name: Arthroscopic Bur
Classification Name: Arthroscope |
Reprocessed devices:
| Manufacturer
| 1 | Description | Model |
|---|---|---|
| Stryker® | 6 Flute Round Bur | 275-846 |
| Stryker® | Barrel Bur 8 Flute | 275-849-000 |
| Stryker® | Standard Round Bur | 275-851-000 |
| Stryker® | Egg Bur 8 Flute Standard | 275-852-000 |
| Stryker® | Bur Pear 8 Flute | 275-853 |
| Stryker® | Aggressive Egg Bur 6 Flute | 275-857-000 |
| Stryker® | Bur Pear Aggressive 6 Flute | 275-858 |
| Stryker® | Barrel Bur 8 Flute | 275-859 |
| Stryker® | Round Bur 6 Flute | 275-866 |
| Stryker® | Round Bur Hollow 6 Flute | 275-940-000 |
| Stryker® | Aggressive Barrel Bur 6 Flute | 275-949 |
| Stryker® | Aggressive Round Bur Hollow | 275-950-000 |
| Stryker® | Round Bur Hollow | 275-950-012 |
| Stryker® | Barrel Bur Aggressive 6 Flute | 275-951-000 |
| Stryker® | Barrel Bur Hollow | 275-951-012 |
| Stryker® | Ultra Aggressive Barrel Bur 4 | 275-955 |
| Stryker® | Aggressive Barrel Bur 6 Flute | 275-959 |
| Stryker® | Ultra Aggressive Bur 4 Flute | 275-965 |
| Stryker® | 6 Flute Barrel Bur | 275-969-000 |
| Predicate
| device(s): | K963332 | Stryker® Thermo-Plastic Shaver Blades | |||
|---|---|---|---|---|---|
| K973195 | Stryker® Total Performance System Shaver Handpiece | ||||
| K982375 | Stryker®,Stryker Hip Arthroscopy Set |
1
Image /page/1/Picture/0 description: The image shows the logo for Alliance. The logo consists of three curved lines above the word "ALLIANCE". The curved lines are thick and black, and they are arranged in a parallel fashion. The word "ALLIANCE" is written in a serif font.
MEDICAL CORPORATION
Arthroscopic Burs can be used to abrade, cut and excise tissue and Device bone; remove loose fragments; and shave away debris in arthroscopic description: surgeries, as well as surgeries of the jaw and sinuses. The Arthroscopic Bur 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. Reprocessed Arthroscopic Burs are intended for resecting tissue and Intended use: 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 Indications surgical procedures of the joints, jaw or sinuses where the cutting and statement: removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. The design, materials, and intended use of the Reprocessed Technological Arthroscopic Burs are identical to the predicate devices. The characteristics: 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.
Bench and laboratory testing was conducted to demonstrate Performance performance (safety and effectiveness) of the Reprocessed data: 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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: K012605
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 reviewed your becares of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is togesty the enactment date of the Medical Device Amendments, or to Conniered prices that have been reclassified in accordance with the provisions of the Federal Food, DR14 de vices that have been receasined in assire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, mailer of the Act include requirements for annual registration, listing of general controls pro reseries, 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can thay be subject to suen additions, 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 I lease oc advised that I Dris assuates viron device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I oderal batates and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK i at 607), adoling (21 CFR Part 820), and if applicable, the electronic forth in also quany 39 movisions (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, us
ta
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
510(k) Number (if known): K012605
Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Burs
Indications for Use: Reprocessed Arthroscopic Burs are indicated for use in Indications for Ose. Treprocessed Alainess where the cutting and ormopedic surgical procedures of the julits, june in patients requiring orthopedic surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) ✓
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
assu (Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012605
12
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Anthroscopic Burs Traditional 510(k)