(134 days)
Not Found
Not Found
No
The summary describes a device for uterine distension using CO2 gas, with no mention of image processing, AI, ML, or related concepts.
No
Explanation: The device's intended use is to distend the uterus for viewing with a hysteroscope, which is a diagnostic or procedural aid, not a therapeutic intervention. It's used to facilitate observation, not to treat a condition. While it may be used during a therapeutic procedure, the device itself does not perform therapy.
No
The device is used to distend the uterus for better visualization during a hysteroscopy, which is a procedure for viewing. It facilitates viewing but does not perform any diagnostic function itself (e.g., analyzing images, detecting abnormalities, or providing a diagnosis). Its purpose is purely to prepare the anatomical site for observation.
No
The device description explicitly states it distends the uterus by filling it with CO2 gas, which requires hardware (a gas source and delivery system) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to distend the uterus with CO2 gas to facilitate viewing with a hysteroscope. This is a procedure performed in vivo (within the living body) to aid in visualization during a surgical or diagnostic procedure.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Description: The description reinforces the intended use of filling the uterine cavity with gas for visualization, which is an in vivo action.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVDs.
Therefore, this device is a medical device used for a procedural purpose within the body, not an in vitro diagnostic test.
N/A
Intended Use / 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.
The AEH-200 is intended to distend the uterus by filling the uterine cavity with CO2 gas to facilitate viewing with a hysteroscope.
Product codes (comma separated list FDA assigned to the subject device)
85 HIG
Device Description
This device is intended to distend the uterus by filling the uterine cavity with gas to facilitate viewing with a hysteroscope.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
uterus / uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance: In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
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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1
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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
2
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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