(86 days)
AR-6400
AR-6300
No
The summary describes a peristaltic pump with upgraded software and display, but there is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device facilitates arthroscopic surgery by controlling irrigation and distention pressure; it does not directly treat a disease or condition.
No
The device is described as an arthroscopy pump intended to control irrigation and pressure during surgery, not to diagnose a condition.
No
The device description explicitly states it is a "roller, peristaltic, arthroscopic pump" and mentions hardware components like a power supply, display, and switch overlays, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide consistent control of intra-articular irrigation and distention pressure during arthroscopic surgery. This is a surgical support device used directly on the patient during a procedure.
- Device Description: The description details a pump that physically manipulates fluids for surgical purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device's function is entirely focused on supporting a surgical procedure performed on the patient.
N/A
Intended Use / Indications for Use
The Arthrex Continuous Wave III Arthroscopy Pump is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
Product codes
HRX
Device Description
The Arthrex Continuous Wave III Arthroscopy Pump is a roller, peristaltic, arthroscopic pump designed with a universal input grade switching power supply allowing the pump to function automatically within voltages ranges found in Europe and in the Americas. The pump is designed with upgraded software, employs a combination vacuum fluorescent and dot matrix display for high visibility, uses membrane type switch overlays for user inputs, and has an added flush function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-articular
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
AR-6400
Reference Device(s)
AR-6300
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
Ko24291
MAR 2 0 2003
PREMARKET NOTIFICATION SUMMARY OF SUBTANTIAL EQUIVALENCE Arthrex Continuous Wave III Arthroscopy Pump
| NAME OF SPONSOR: | Arthrex, Inc.
2885 S. Horseshoe Drive
Naples, Florida 34104 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Requlatory Affairs Specialist
Arthrex, Inc.
Telephone: (239) 643-5553 ext. 1251
FAX: (239) 430-3494
E-mail: sfoust@arthrex.com |
| TRADE NAME: | Arthrex Continuous Wave III Arthroscopy
Pump |
| COMMON NAME: | Pump |
| CLASSIFICATION: | Arthroscope
21 CFR 888 1111 |
DEVICE PRODUCT CODE: HRX
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Continuous Wave III Arthroscopy Pump is a roller, peristaltic, arthroscopic pump designed with a universal input grade switching power supply allowing the pump to function automatically within voltages ranges found in Europe and in the Americas. The pump is designed with upgraded software, employs a combination vacuum fluorescent and dot matrix display for high visibility, uses membrane type switch overlays for user inputs, and has an added flush function.
The Arthrex Continuous Wave III Arthroscopy Pump is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
SUBSTANTIAL EQUIVALENCE
The Arthrex Continuous Wave III Arthroscopic Pump is a functional equivalent of the currently marketed AR-6400 and the discontinued AR-6300 Arthrex arthroscopic pumps. The subject pump retains current functions and is determined by Arthrex, Inc. to be substantially equivalent to its Arthrex pump predecessors and other currently marketed predicate devices.
The addition of a universal input grade switching power supply, of an improved visual display, of an autoclavable remote, and of an upgrade software package does not affect the safety and effectiveness of the subject device when compared to its Arthrex pump predecessors and other predicate devices.
Image /page/0/Picture/11 description: The image shows a sequence of numbers. The numbers are "000005". The numbers are black and the background is white.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human form, represented by three abstract shapes that resemble profiles facing right. The shapes are arranged in a way that suggests a sense of unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Ms. Sally Foust, RAC Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K024291
Trade/Device Name: Arthrex Continuous Wave III Arthroscopy Pump Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: December 20, 2002 Received: December 24, 2002
Dear Ms. Foust:
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.
2
Page 2 - Ms. Sally Foust, RAC
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), 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) you may obtain. 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 vours.
Mark A. Milken
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
3
K024291 510(k) Number (if known) _
INDICATIONS FOR USE:
The Arthrex Continuous Wave III Arthroscopy Pump is intended to provide consistent, non-pulsing control of intra-articular irrigation and distention pressuring during all phases of arthroscopic surgery.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter
Use
(Per 21 CFR 801.109)
Mark A Milliken
vision Sign-Off on of General, Restorative cological Devices