(56 days)
The function of the Safe T Retractable Blood Collection Device is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needle stick injury.
The Safe T Retractable Blood Collection Device is comprised of three components, a body, plunger and hub. The thread in the hub component matches that of all regular tube holders. The space within the holder is sufficient to fit all regular multi-sample needles after retraction. The device is supplied fully assembled, primed and ready for use, bulk packaged in polyethylene bags of 10 units. The device is non patient contacting and thus is sold non sterile.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Safe T Retractable Blood Collection Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing acceptance criteria and conducting studies to prove a device meets those criteria in the same way a novel device might.
Therefore, the document does not contain the specific information requested regarding acceptance criteria, reported device performance against those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or details on training sets.
Instead, the submission for the Safe T Retractable Blood Collection Device relies on the following for its substantial equivalence claim:
- Comparison of Design and Technological Characteristics: The document states that the Safe T Retractable Blood Collection Device is substantially equivalent to the Retractable Technologies Vanish Point Tube Holder (predicate device K971763) based on "Design similarities between the proposed device and the currently marketed device," and "Technological Characteristics. The proposed Safe T Retractable Blood Collection Device and currently marketed Retractable Technologies Vanish Point Tube Holder - K971763 are similar in terms of materials of construction, performance characteristics, and basic design."
- Intended Use: The device has "the same intended use and indication statement as the predicate device."
- Operating Principle: The device "uses the same operating principle as that of its predicate."
- Performance Testing: The document briefly states, "Bench Testing and Simulated Use testing were performed." However, it does not provide any details about the acceptance criteria used for these tests, the results, sample sizes, or how they specifically demonstrate substantial equivalence beyond a general statement.
In summary, the provided text does not offer the detailed information required by your request for acceptance criteria and specific study results. The 510(k) process for this device focused on showing its similarity to an existing device rather than providing quantitative performance metrics against pre-defined acceptance criteria as would be expected for a novel device.
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Safe T Medical Devices Limited Safe T Retractable Blood Collection Device
K041941
7/14/2004
/ j2
510K Summary Of Safety and Effectiveness SEP 1 3 2004 Safe T Medical Devices Limited July 14, 2004
】. Sponsor Name Safe T Medical Device Limited PO Box 1, Portland House, Station Rd Ballasalla, Isle of Man IM99 6AB, British Isles
Telephone: 00441514271271 Contact Individual: Peter Jeffrey
- 2 Device Name
Proprietary Name: Safe T Retractable Blood Collection Device Common/Usual Name: Blood Collection Tube Holder
Panel: General Hospital Classification Name: needle, hypodermic, single lumen CFR Number: 880:5570 Product Code: FMI
-
3 Identification of Predicate or Legally Marketed Device
Retractable Technologies Vanish Point Tube Holder - K971763 -
ব Device Description
The Safe T Retractable Blood Collection Device is comprised of three components, a body, plunger and hub. The thread in the hub component matches that of all regular tube holders. The space within the holder is sufficient to fit all regular multi-sample needles after retraction. The device is supplied fully assembled, primed and ready for use, bulk packaged in polyethylene bags of 10 units. The device is non patient contacting and thus is sold non sterile. -
న్ Intended Use
The function of the Safe T Retractable Blood Collection Device is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needle stick injury. The Safe T Retractable Blood Collection Device
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Safe T Medical Devices Limited Safe T Retractable Blood Collection Device
K 041941
7/14/2004 2 of 2
works like a conventional tube holder except for its ability to retract the contaminated needle inside of the tube holder immediately after blood collection.
- Comparison of Technological Characteristics 6. The Safe T Retractable Blood Collection Device described in this submission is substantially equivalent to the predicate, the Retractable Technologies Vanish Point Tube Holder - K971763. Substantial equivalence of the Safe T Retractable Blood Collection Device is based on:
- Design similarities between the proposed device and the currently marketed device .
- Technological Characteristics. The proposed Safe T Retractable Blood Collection . Device and currently marketed Retractable Technologies Vanish Point Tube Holder - K971763 are similar in terms of materials of construction, performance characteristics, and basic design.
The intended use, technological characteristics of the materials and processes used in the application and safety characteristics of the Safe T Retractable Blood Collection Device support the concept of substantial equivalence. The Safe T Retractable Blood Collection Device has the same intended use and indication statement as the predicate device. The device has the same technological characteristics and operating design to that of its predicate. The Safe T Retractable Blood Collection Device uses the same operating principle as that of its predicate.
- 7 Performance Testing
Bench Testing and Simulated Use testing were performed.
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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 department's name around the perimeter. In the center of the seal is a stylized image of an eagle.
SEP 1 3 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Safe T Medical Devices Limited C/O Ms. Debbie Iampietro QRC Consulting P.O. Box 1070 Conway, New Hampshire 03818-1070
Re: K041941
Trade/Device Name: Safe T Retractable Blood Collection Device Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 1, 2004 Received: September 3, 2004
Dear Ms. Iampietro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the referenced above and have acterinalosure) 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 Anticiluments, or to de rood mass ic Act (Act) that do not require approval of a premarket the rodelar Food, Drag, and Ocau may, therefore, market the device, subject to the general approval upprivation (1 the Act. The general controls provisions of the Act include controls provisions of an 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 (FMA), it may of subject to tack adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Iampietro
Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast that FDA has made a determination that your device complies with other requirements modi that I DA nas made statutes and regulations administered by other Federal agencies. or the rict of all - suith all the Act's requirements, including, but not limited to: registration r ou must compry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle histing (21 er reav 001), a may systems (QS) regulation (21 CFR Part 820); and if requirements as bet form product radiation control 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 yourse cognitial equivalence of your device of your device to a premaired 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), rr you don't the Office of Compliance at (301) 594-4618. 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 maj obtain 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.
Chiu Lin, 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
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Indications for Use
510(k) Number (if known):_K041941
Device Name:_Safe T Retractable Blood Collection Device
Indications For Use:
The function of the Safe T Retractable Blood Collection Device is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needle stick injury.
Prescription Use _X (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)
Anton V. Min
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: Joy 1941
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).