(112 days)
Not Found
No
The summary describes a mechanical device for tissue sampling with integrated visualization, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is used for diagnostic purposes (visualizing and obtaining a tissue sample for histological evaluation) rather than treating a disease or condition.
No.
The device is used to visualize the interior of the uterus and obtain an endometrial tissue sample for histological evaluation, but it is not indicated for diagnosis itself. The histological evaluation of the sample would be the diagnostic step performed by a pathologist.
No
The device description clearly states it consists of a disposable aspirating curette and a reusable fiberoptic hysteroscope, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) to visualize and collect a tissue sample.
- The primary function of this device is a surgical/procedural tool for tissue collection and visualization. While the collected tissue will likely be sent for in vitro histological evaluation (which is an IVD process), the device itself is not performing the diagnostic test.
- The description focuses on the mechanical and optical aspects of the device for tissue removal and visualization within the uterus. It doesn't describe any components or processes for analyzing the tissue by the device itself.
In summary, the Optical Aspirating Curette is a medical device used to obtain a sample for subsequent in vitro diagnostic testing, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.
Product codes
85 HCY, 85 HIH
Device Description
Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.
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Pi92
1 1898 MAY
510(k) Summary Imagyn Medical Technologies , Inc. Optical Aspirating Curette (OAC)
General Information on Submitter: I.
Imagyn Medical Technologies, Inc. Name: 5 Civic Plaza, Suite 100 Address: Newport Beach, CA 92660 (714) 362-2500 Phone: (714) 362-2520 Fax:
Ronald H. Bergeson Name of Contact Person: January 8, 1998 Date Summary Prepared:
General Information on Device II.
Name: Optical Aspirating Curette
Classification Name:
Obstetric-gynecologic general manual instrument, uterine curette (curette portion of device), 21 C.F.R. § 884.1175
Hysteroscope and accessories (hysteroscope portion of device), 21 C.F.R. §884.1690
III. Predicate Devices:
The flexible fiberoptic hysteroscope component is similar to the MicroSpan Hysteroscope (510(k) No. K961688).
The disposable curette component is similar to the Milex "Tis-U-Trap" Uterine Suction Curette, Milex, (510(k) No. K760264); and the Pipelle "Endometrial Suction Curette", (510(k) No. K881456).
Description of the Device: IV.
Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure.
V. Intended Use:
The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.
VI. Technological Characteristics of Device Compared to Predicate Device:
Optical Aspirating Curette (OAC) Imagyn Medical Technologies, Inc. 01/07/98
1
The OAC uses the same type of curette as the Milex “Tis-U-Trap” curette device, and the same type
hysteroscope as the Imagyn “MicroSpan” Hysteroscope device.
Optical Aspirating Curette (OAC)
Imagyn Medical Technologies, Inc.
01/08/98
2
Image /page/2/Picture/0 description: The image shows a black and white logo. The logo appears to be a stylized representation of an eagle or bird, with three distinct, curved lines forming the head and wings. The logo is partially obscured on the left side, with some text visible, possibly indicating the name of an organization or department.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY --1688
Mr. Ronald H. Bergeson Corporate Director, Regulatory Affairs IMAGYN Medical Technologies, Inc. 27651 La Paz Road Laguna Niguel, CA 92677
Re: K980096
Optical Aspirating Curette Dated: March 13, 1998 Received: March 16, 1998 Regulatory Class: II 21 CFR §884.4530/Procode: 85 HCY 21 CFR $884.1690/Procode: 85 HIH
Dear Mr. Bergeson:
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, 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 probibitions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalient determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product 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/dsmaddsmam.html".
Sincerely yours.
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
3
INDICATION FOR USE FORM
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|---|---|---|---|---|---|
| 510 (k) Number (if known): | K980096 | ||||
| Device Name: | Optical Aspirating Curette |
Indications for Use:
:
《
The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sattler/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980096
Prescription Use
(Per 21 CFR 801.1091
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Optical Aspirating Curette (OAC) Imagyn Medical Technologies, Inc.
01/08/98