(74 days)
The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
Spectra, GLASS LOR SYRINGE
This document is a 510(k) clearance letter from the FDA for a medical device called "Spectra, GLASS LOR SYRINGE". This type of letter generally does not include detailed study results, acceptance criteria, or performance data beyond stating that the device is substantially equivalent to a predicate. The letter confirms the device can be marketed based on its equivalence.
Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be available in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document is an FDA clearance letter based on substantial equivalence, not a detailed study report. It does not contain specific acceptance criteria or performance metrics beyond the general statement of substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The 510(k) letter does not include details about specific test set sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. Information on expert involvement for ground truth establishment for a test set is not present in this regulatory clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Details on adjudication methods are not included in this document.
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
- Cannot be provided. This device is a "GLASS LOR SYRINGE" (Loss of Resistance Syringe), a physical medical device. It is not an AI algorithm, and therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. As a physical syringe, the concept of "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. This information is not part of an FDA clearance letter for a physical device. For a device like a syringe, performance is typically assessed through physical and mechanical testing against recognized standards or direct comparison to a predicate, rather than through complex ground truth establishment methods relevant to diagnostic algorithms.
8. The sample size for the training set
- Cannot be provided. As this is a physical device and not an AI algorithm, there would be no "training set" in the computational sense.
9. How the ground truth for the training set was established
- Cannot be provided. This is not applicable to a physical device.
Summary based on the provided text:
The provided document is an FDA 510(k) clearance letter for the "Spectra, GLASS LOR SYRINGE." This letter indicates that the device has been deemed substantially equivalent to legally marketed predicate devices. The basis for this determination is typically a comparison of the device's technological characteristics and performance to those of the predicate.
While the letter confirms the device meets the regulatory requirements for market entry, it does not contain the detailed study data, acceptance criteria, or performance reports that would include information on sample sizes, expert involvement, ground truth establishment, or specific metrics like sensitivity, specificity, or effect sizes. Such detailed information would typically be found in the manufacturer's 510(k) submission itself, which is not provided here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 28 2008
Mr. Scott Henderson International Engineering Manager Spectra Medical Devices, Incorporated 260-F&H Fordham Road Wilmington, Massachusetts 01887
Re: K082674
Trade/Device Name: Spectra, GLASS LOR SYRINGE Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 12, 2008 Received: September 15, 2008
Dear Mr. Henderson:
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 application (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 such 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.
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Page 2 - Mr. Henderson
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 requircments 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 begin marketing your device as described in your Section 510(k) promarket 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clive
Chiu S. Lin. Ph. D Division 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
1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Spectra, GLASS LOR SYRINGE Device Name:
Indications for Use:
The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
Prescription Use X (Part 21 CFR 801 Subpert D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NECESSARY)
concurrence of cdrh, office of device evaluation (ode)
SECTION 3, PAGE 1
Anton Vimin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082674
§ 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).