(87 days)
Single use disposable syringe to inject fluids into, or retract fluids from the body
When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle.
Not Found
This is a 510(k) clearance letter for the MINRAD DRTS Light Saber™ Syringe. It does not contain information about the acceptance criteria and study proving device performance as typically expected for imaging algorithm related devices.
However, based on the Indications for Use section (page 2), there is a performance claim made for the device when used with another system. I will treat this claim as an "acceptance criterion" in the absence of a detailed study report.
Here's an attempt to answer your questions based on the limited information provided in this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claimed | Reported Device Performance |
|---|---|
| Accuracy of +/- 3mm from the laser path when using a 10 cm needle (when used with the DRTS™ Laser Alignment System) | The document states this as a feature/claim of the device, implying it meets this performance. No separate "reported performance" is provided. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in this document.
- Data Provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This document does not describe a study involving expert readers or ground truth establishment in the context of an AI/algorithm.
4. Adjudication method for the test set
- Not applicable as no such study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this document does not describe an MRMC comparative effectiveness study. This is a medical device clearance for a syringe, not an AI/imaging algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is for a physical medical device (syringe). The "accuracy" claim refers to its mechanical guidance capability.
7. The type of ground truth used
- The "ground truth" for the +/- 3mm accuracy claim would likely be based on physical measurements and engineering specifications, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable, as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/algorithm device.
Summary of Limitations:
This document is a 510(k) clearance letter for a syringe, a physical medical device. It is not a study report for an imaging algorithm or AI device. Therefore, most of the questions related to AI/algorithm performance, training/test sets, expert ground truth, and comparative effectiveness studies are not applicable or cannot be answered from the provided text. The only "performance claim" mentioned is a mechanical accuracy specification for the syringe when used with a laser alignment system.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1998
Mr. Thomas L. Parker ·Director, Regulatory Affairs MINRAD™ Incorporated 6576 East Quaker Street Orchard Park, New York 14127-2593
Re : K981140 MINRAD DRTS Light Saber™ Syringe Trade Name: Requlatory Class: II Product Code: FMF Dated: March 23, 1998 Received: March 30, 1998
Dear Mr. Parker:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Pleáse note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Parker
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html"
Sincerely yours,
Timothy A. Ulatowski
A. Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5
INDICATIONS FOR USE
MINRAD LIGHT SABER™ SYRINGE
"Single use disposable syringe to inject fluids into, or retract fluids from the body"
"When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle."
Patricia Cucciate
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devi 510(k) Number K98 1
Prescription use ✓
(Per 21CFR 801.109)
§ 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).