(130 days)
The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.
The Procedur-10 device is a piston syringe
I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for a piston syringe called "Procedur-10." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer your request.
The K042486 submission is for a Class II medical device (Piston Syringe) and focuses on demonstrating substantial equivalence to a predicate device (Becton Dickinson Single-Use Hypodermic Syringes K980987). Substantial equivalence typically relies on comparing technological characteristics and intended use, rather than extensive clinical performance studies with acceptance criteria as you've requested for AI/software devices.
Therefore, I cannot extract the information required to fill out the table and answer your questions regarding acceptance criteria, study details, and AI-related aspects.
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JAN 2 1 2005
510(K) SUMMARY
| Sponsor: | Avanca Medical Devices, Inc.800 Bradbury SEAlbuquerque, NM 87106 |
|---|---|
| Submitted By: | Ferguson MedicalConsultant to Avanca Medical Devices, Inc. |
| Contact Information: | Phone: 505.272.7000FAX: 505.272.7000 |
| Classification Name: | Piston Syringe |
| Common/Usual Name: | Syringe, injection syringe, aspiration syringeand others |
| Proprietary Name: | Procedur-10 |
| Classification Number: | 21 CFR 880.5860/Procode 90 FMF |
| Substantial Equivalence: | Becton Dickinson Single-Use HypodermicSyringes (K980987) |
| Device Description: | The Procedur-10 device is a piston syringe |
| Intended Use: | The Procedur-10 device is intended to be usedto inject fluids into, or withdraw fluids from,the body |
| Technological Characteristics: | The Procedur-10 device utilizes two syringesassembled in a plastic holder. The syringeplungers are connected by a pulley. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Avanca Medical Devices, Incorporated C/O Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road, NE #931 Albuquerque, New Mexico 87111
Re: K042486
Trade/Device Name: Procedur10 Syringe Device Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 12, 2004 Received: December 27, 2004
Dear Mr. Ferguson:
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 referenced above and has not osure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 approvisions 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 (1 Wry, it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Ferguson
Please be advised that FDA's issuance of a substantial equivalence determination does not r least be act vised that 122 re tounination that your device complies with other requirements Incall that t Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I edelar states and regirements, including, but not limited to: registration 1 ou must contin1 will as art 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quarty is nontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anon you to began finding of substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific at rio for your at (240) 276-0115. 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 from the may other generational 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/industry/support/index.html.
Sincerely yours,
Clair Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
KO42486
510(k) Number (If known): ###2846=
Device Name: Procedur-10 .
Indications For Use:
The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.
Prescription Use __ XX (Part 21 CFR 801 Subpart D) And/Or
Over-The- Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Intin 20,200
(Division Sign-Off) Olvision of Anesthesiclogy, General Hospital, Infection Control, Dental Devices
510(k) Number: K442486
Page 1 of 1
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).