(134 days)
This device is intended to distend the uterus by filling the uterine cavity with CO2 gas to facilitate viewing with a hysteroscope.
This device is intended to distend the uterus by filling the uterine cavity with gas to facilitate viewing with a hysteroscope.
The provided text describes a medical device, the BEI Medical Systems Automatic Electronic Hysteroscopic Insufflator (AEH-200), and its premarket notification (510(k)) summary. However, it does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria in the format requested.
The document primarily focuses on:
- Device Identification: Name, common name, classification, and equivalent devices.
- Intended Use: To distend the uterus with CO2 gas for hysteroscopic viewing.
- Technological Summary: Compliance with Draft: August 1, 1995 Submission Guidance for a 510(k) Submission on Hysteroscopic and Laparoscopic Insufflators.
- Nonclinical Performance: Mentions "In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters."
- Conclusion: Device is comparable to existing devices and has no safety issues.
- FDA Clearance Letter: Confirming substantial equivalence.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what needs further information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters." |
| Compliance with Draft: August 1, 1995 Submission Guidance for a 510(k) Submission on Hysteroscopic and Laparoscopic Insufflators (Specifically Sections II B through II F). | Demonstrated compliance. |
| Device comparable to similar devices already available. | Proved comparable. |
| No safety issues. | Not demonstrated any safety issues. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: "In house testing." No country of origin or retrospective/prospective nature specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was "in house testing" for compliance with label claims and guidance, not a clinical study requiring expert ground truth for interpretation of medical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was engineering/performance testing, not a study requiring adjudication of expert readings.
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 MRMC study was done. This device is an insufflator, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For performance criteria related to the device's function (e.g., CO2 flow, pressure), the "ground truth" would be established engineering specifications and measurement standards. The document mentions "label claims" which would define these.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "in house testing" refers to performance verification.
9. How the ground truth for the training set was established:
- Not applicable.
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BEI MEDICAL SYSTEMS
MED SYSTEM
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Tel 201.489.4222 Fax 201.489.6745
K971492
Plol
- 5 1997
PREMARKET NOTIFICATION [510(K)] SUMMARY
- BEI Medical Systems Company, Inc. l. Submitter: 83 Hobart Street Hackensack, New Jersey 07601 (201) 489-4222 (phone) (201) 489-6745 (fax) Lorraine T. Montemurro, RN 11. Contact Person: Director, Regulatory Affairs & Quality Assurance April 24, 1997 III. Date: IV. Device Name: Automatic Electronic Hysteroscopic Insufflator - AEH-200 Hysteroscopic Insufflator V. Common Name: Hysteroscopic Insufflator (per 21 CFR section 884.1700) VI. Classification Name: Hamou Microhysteroflator - Karl Storz VII. Equivalent Device: Hystero-Insufflator Electronic - Wisap This device is intended to distend the uterus by filling the uterine VIII. Device Description: cavity with gas to facilitate viewing with a hysteroscope. The AEH-200 is intended to distend the uterus by filling the uterine IX. Intended Use: cavity with CO2 gas to facilitate viewing with a hysteroscope. ×. This device has demonstrated compliance with the recommendations Technological Summary: in the Draft: August 1, 1995 Submission Guidance for a 510(k) Submission on Hysteroscopic and Laparoscopic Insufflators. Specifically Sections II B through II F. XI. Nonclinical Performance: In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters. Conclusion: XII. This device has proved comparable to similar devices already available and has not demonstrated any safety issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Re: K971492
Ms. Lorraine Montemurro Director, Regulatory Affairs & Quality Assurance BEI Medical System Co., Inc. 83 Hobart Street __ _ _ _ _ _ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hackensack, New Jersey 07601
Automatic Electronic Hysteroscopic Insufflator (AEH-200) Dated: July 31, 1997 ... . Received: August 1, 1997 Regulatory class: II 21 CFR §887.1700/Product code: 85 HIG
Dear Ms. Montemurro:
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 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 misbranion.
If your device is classified (see above) into either class III (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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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.
W. Hiau 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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BEI MEDICAL SYSTEMS
83 Hobart Street Hackensack, NJ 07601
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510(k) Number (if known): _ New
Device Name: Automatic Electronic Hysteroscopic Insufflator
Indications For Use:
This device is intended to distend the uterus by filling the uterine cavity with CO2 gas to facilitate viewing with a hysteroscope.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roter R. Sitting/
Division of OM
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971492
Prescription Use ___ (Per 21 CFR 801.109) OR
Over-The-Counter Use _
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§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.