(21 days)
I DECLEAR THAT THE PIVOTING COMPENSATION FILTER FOR THE HEAD IS FOR ROTATIONAL examinations of digital and dsa cerebral arteriograms and is substantially equivlent to previously accepted device Little Prism K913659C.
PIVOTING COMPENSATION FILTERS FOR THE HEAD, PCF Head
This document is a 510(k) clearance letter from the FDA for a device called "Pivoting Compensating Filters for the Head (Cerebral Arteriograms)". It states that the device is substantially equivalent to a previously accepted device.
Unfortunately, this letter and the associated "Indications For Use" form do not contain any information about acceptance criteria or a study proving the device meets them. The document is a regulatory approval, not a technical performance report.
Therefore, I cannot provide the requested information from the given text.
To address your request, if this were a document that contained the relevant information, here's how I would structure the answer for a hypothetical study:
Hypothetical Study Information (Information not available in the provided text)
Since the provided documents are a 510(k) clearance letter and an Indications For Use form, they do not contain the detailed technical study information requested. The following sections are presented as a template for what would be provided if such information were available.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [e.g., Sensitivity ≥ 90%] | [e.g., Sensitivity: 92.5% (95% CI: 90.1-94.8%)] |
| [e.g., Specificity ≥ 85%] | [e.g., Specificity: 88.0% (95% CI: 85.5-90.2%)] |
| [e.g., Image Quality Score (e.g., 4.0 out of 5)] | [e.g., Mean Image Quality Score: 4.2] |
| [e.g., Reduction in dose by X%] | [e.g., Average dose reduction: 25%] |
2. Sample Size and Data Provenance for Test Set
- Sample Size: [e.g., 500 cerebral arteriogram cases]
- Data Provenance: [e.g., Retrospective data collected from multiple hospitals in the United States and Canada]
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: [e.g., 3]
- Qualifications: [e.g., Board-certified neuroradiologists with an average of 15 years of experience in interpreting cerebral angiograms.]
4. Adjudication Method for Test Set
- Adjudication Method: [e.g., 2+1 (Primary reads by two experts, with a third expert adjudicating any discrepancies).]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted: [e.g., (Yes/No)]
- Effect Size (If Yes): [e.g., Human readers using AI assistance demonstrated a statistically significant improvement in lesion detection accuracy by an average of 10% (from 80% to 90%) compared to reading without AI assistance. Reader confidence scores also increased by an average of 0.5 points on a 5-point scale.]
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Conducted: [e.g., (Yes/No)]
- Performance (If Yes): [e.g., The algorithm achieved an AUC of 0.95 for detecting cerebral vascular anomalies, with a sensitivity of 93% and specificity of 89% at a predefined operating point.]
7. Type of Ground Truth Used (Test Set)
- Ground Truth Type: [e.g., Expert consensus based on clinical follow-up, surgical findings, or cross-modality imaging (e.g., MRA, CTA) where available.]
8. Sample Size for Training Set
- Sample Size: [e.g., 5,000 cerebral arteriogram cases]
9. How Ground Truth for Training Set Was Established
- Ground Truth Method: [e.g., Ground truth for the training set was established through a combination of expert radiologist annotations (single reader annotation for efficiency, followed by an automated quality check for consistency) and correlating with existing radiological reports and structured clinical data.]
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jean A: Vézina, M.D. President and Medical Advisor OCTOSTOP, INC. Casier Postal 1476 Succ. St-Laurent, Montreal .. QC., Canada H4L 4ZI
Re: K972766 Pivoting Compensating Filters for the Head (Cerebral Arteriograms) Dated: July 8, 1997 Received: July 24, 1997 . Regulatory Class: II 21 CFR 892.1680/Procode: 90 KPR
AUG 1 4 1997
Dear Dr. Vézina:
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, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 concerning your device in the Federal Register. Please note: 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 Radiation Control provisions, or other Federal laws or regulations.
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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_PIVOTING COMPENSATION FILTERS FOR THE HEAD, PCF Head
Indications For Use:
I DECLEAR THAT THE PIVOTING COMPENSATION FILTER FOR THE HEAD IS FOR ROTATIONAL examinations of digital and dsa cerebral arteriograms and is substantially equivlent to previously accepted device Little Prism K913659C.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elbert A. Sevyer
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K972746
Prescription Use_ (Per 21 CFR 801.109)
:
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.