(51 days)
The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.
The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.
The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.
One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.
The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.
I am sorry, but the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance.
The document is a 510(k) submission for the Unifine Pentip, claiming substantial equivalence to the Becton Dickinson Microfine Pentip. While it states that the performance is "substantially equivalent," it does not provide specific acceptance criteria, quantitative performance metrics, or details about a study conducted to demonstrate this equivalence.
Here's a breakdown of what cannot be extracted from the provided text:
- Acceptance Criteria Table: No specific criteria (e.g., success rate, accuracy, failure rate) are mentioned.
- Reported Device Performance: No quantitative performance data is provided for the Unifine Pentip.
- Sample size for the test set: Not mentioned.
- Data provenance (country, retrospective/prospective): Not mentioned.
- Number of experts used for ground truth: Not applicable, as no such study is described.
- Qualifications of experts: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned.
- Effect size of human reader improvement: Not applicable.
- Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable, as no study establishing ground truth is described.
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm.
- How ground truth for training set was established: Not applicable.
The document focuses on regulatory approval based on substantial equivalence to an existing marketed device, citing similarity in design, intended use, and operational principles, and noting that the product has been marketed in Europe without adverse reports. It does not include a detailed clinical or performance study with quantified acceptance criteria as might be expected for an AI/algorithm-based device.
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DEC - 4 1997
510k SUBMISSION
UNIFINE PENTIPS
SUMMARY
Submitted by:
Robert E. Shaw Owen Mumford, Inc. 849 Pickens Industrial Dr. Suite 14 Marietta, GA 30062
Unifine Pentip Device Name: Becton Dickinson Microfine Substantial Equivalence: Hypodermic Single Lumen Needle Classification Name:
Owen Mumford has been marketing the Unifine Pentip throughout Europe for over 12 months without any adverse customer reports. The product has also been sold throughout Europe by the original manufacture under the name "Braun Omnican."
DESCRIPTION
The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.
INTENDED USE
The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.
OPERATIONAL
The principle operation and design concepts of the Unifine Pentip are substantially equivalent to that of the BD Microfine Pentip.
PERFORMANCE
Performance of the Unifine Pentip, when compared to the BD Microfine, is substantially equivalent.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert E. Shaw ·Vice President Owen Mumford, Incorporated 849 Pickens Industrial Drive, Suite 14 Marietta, Georgia 30062
DEC - 4 1997
K973899 Re : Unifine Pentips Trade Name: Requlatory Class: II Product Code: FMI Dated: October 14, 1997 Received: October 14, 1997
Dear Mr. Shaw:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Shaw
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timoth A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
.Enclosure
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Image /page/3/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '973899'. The numbers are written in a cursive style, with some connections between the digits.
510(k) Number (if known): Not known
UNIFINE PENTIPS Device Name:
Indications for use:
The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.
The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.
One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.
| Concurrence of CDRH, Office of Device Evaluation (ODE). | |
|---|---|
| (Division Sign-Off) | Patricia Cucente |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| F 0(k) Number | 8973899 |
| Prescription Use | X |
| OR Over-the-Counter Use |
(Per 21CFR 801.109)
(Optional Format 1-2-96)
§ 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).