(79 days)
The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin.
The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceur icul directly to the patient. As an alternative use the product will allow administration of the pharmacenty to to the patient via an intravenous port, heparin lock, or saline lock.
The UltiCare Disposable Syringes and Needles and Insulin Syringes are standard piston type syringes with permanently attached (unibody) needles. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, a plunger rod, and a hypodermic single lumen needle. The UltiCare Disposable Syringes and Insulin Syringes are non-toxic and non-pyrogenic, and are available in a variety of combinations of syringe sizes (0.3 to 3.0 cc (ml)), needle sizes (31 to 22 gauge), and needle lengths (5/16" to 1.5").
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the way typically found for AI/ML-based medical devices or diagnostic tools. The document is a 510(k) summary for a traditional medical device (syringes and needles), which focuses on "substantial equivalence" to predicate devices rather than novel performance metrics and validation studies common for AI.
Therefore, I cannot populate the requested table and answer the questions related to AI/ML device performance validation. The document describes the device, its intended use, and lists predicate devices, but it does not include data on acceptance criteria, a test set, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm.
Here's why the information isn't available in the provided text:
- Device Type: The device is a traditional disposable syringe and needle, not an AI/ML-based diagnostic or imaging device. Its clearance hinges on demonstrating substantial equivalence to existing devices in terms of materials, design, and intended use, rather than demonstrating specific accuracy or performance metrics against a ground truth dataset.
- 510(k) Summary Nature: A 510(k) summary (especially for traditional devices) typically outlines the device description, intended use, predicate devices, and a comparison demonstrating substantial equivalence. It generally does not include extensive clinical study data with detailed performance metrics, especially not in the context of AI/ML validation.
- Lack of Performance Data: There are no sections discussing performance metrics like sensitivity, specificity, AUC, or a "reported device performance" that would align with acceptance criteria for a diagnostic algorithm. The "performance" for these devices would typically relate to sterility, material compatibility, and physical dimensions, which are not outlined in such a summary.
Therefore, I must state that the requested information cannot be extracted from the provided document.
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Ulti Med UltiCare™ Disposable Syringes and Needles Traditional 510(k)
510(k) Summary
NOV 3 U 2006
Submitter
Date Prepared October 10, 2006
Ulti Med Inc. 287 East Sixth Street St. Paul, Minnesota Contact Person: Thomas E. Erickson Telephone: (651) 291-7909 Fax: (651) 291-7074
Name of Device
| Common Name: | Disposable syringes and needles, insulin syringes |
|---|---|
| Proprietary Name: | UltiCare™ Disposable Syringes and Needles and Insulin Syringes(numerous sizes and combinations varying between the smallest 0.3ccx 31G x 5/16" and the largest 3.0cc x 22G x 1.5") |
| Classification Name: | Piston Syringe, Hypodermic single lumen needles |
| Regulation: | 880.5860, 880.5570 |
| Class: | Class II |
| Product Code: | FMF/FMI |
Predicate Devices
The UltiCare Disposable Syringes and Needles are substantially equivalent in intended use, function and basic composition to the currently marketed UltiCare Low Dead Space Disposable Syringe (1 ml/cc x 22 G x 1.5"), K994230, and to the UltiCare Disposable Syringe (3 ml/cc, 22 G x 1.5"), K033794.
The Insulin Syringes are substantially equivalent in intended use, function and basic composition to the currently marketed Becton Dickinson BD Insulin Syringes – Ultra-Fine™ and Ultra-Fine™ II, K024112.
Device Description
The UltiCare Disposable Syringes and Needles and Insulin Syringes are standard piston type syringes with permanently attached (unibody) needles. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, a plunger rod, and a hypodermic single lumen needle. The UltiCare Disposable Syringes and Insulin Syringes are non-toxic and non-pyrogenic, and are available in a variety of combinations of syringe sizes (0.3 to 3.0 cc (ml)), needle sizes (31 to 22 gauge), and needle lengths (5/16" to 1.5").
Intended Use
The UltiCare disposable syringes and needles are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.
The Insulin Syringes are intended for subcutancous injection of U-100 insulin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
JUN 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ulti Med, Incorporated C/O Ms. Carole Stamp Regulatory and Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334
Re: K062702
Trade/Device Name: Insulin Syringes, UltiCare™ Disposable Syringes and Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: September 8, 2006 Received: September 11, 2006
Dear Ms. Stamp
This letter corrects our substantially equivalent letter of November 29, 2006.
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 (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 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
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Page 2 - Ms. Stamp
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.
This letter will allow you to continue 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 (240) 276-0115 http://www.fda.gov/cdrb/organiz.html#OC for OC organization structure). 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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Ulti Med UltiCare™ Disposable Syringes and Needles Traditional 510(k)
01
Indications for Use
510(k) Number: K062702
Device Name: Insulin Syringes
Indications For Use:
The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin.
Prescription Use AND/OR (21 CFR 801.Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Surg Quane
euthesiology, General Hospits " onlivi, Dental Device
Ka2702
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Ulti Med UltiCare™ Disposable Syringes and Needles Traditional 510(k)
2 of 2
Indications for Use
510(k) Number: K062702
Device Name: UltiCare™ Disposable Syringes and Necdles
Indications For Use:
The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceur icul directly to the patient. As an alternative use the product will allow administration of the pharmacenty to to the patient via an intravenous port, heparin lock, or saline lock.
Prescription Use AND/OR (21 CFR 801.Subpart D)
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)
Ald C. Chyn for mw 11/28/2006
§ 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).