(112 days)
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.
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.
This K980096 510(k) summary for the Imagyn Medical Technologies, Inc. Optical Aspirating Curette (OAC) does not contain the detailed acceptance criteria or the study data that "proves" the device meets these criteria in the way a modern AI/ML device submission would.
Instead, this is a traditional medical device submission based on substantial equivalence to predicate devices. The "study" here is essentially the argument for functional and technological equivalence, rather than a performance study with acceptance criteria and statistical analysis as is common for AI/ML.
Let's break down why this information is missing based on the provided text, and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Inferred) |
|---|---|
| Visualization of uterine interior: OAC should provide similar visualization capabilities to the predicate hysteroscope. | The OAC accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, enabling visualization of the uterine cavity. This function is stated as similar to the MicroSpan Hysteroscope (K961688). |
| Obtaining endometrial tissue sample adequate for histological evaluation: OAC should be able to collect tissue samples of sufficient quality and quantity for pathology, similar to predicate curettes. | The OAC is a disposable aspirating curette intended to remove tissue from the uterus by scraping and aspirating. It is stated to be similar to the Milex "Tis-U-Trap" Uterine Suction Curette (K760264) and the Pipelle "Endometrial Suction Curette" (K881456). The intended use explicitly states "obtaining an endometrial tissue sample adequate for histological evaluation." |
| Safety and Biocompatibility: The materials and design should be safe for uterine use and biocompatible. | Not explicitly detailed, but assumed to be equivalent to predicate devices based on the 510(k) clearance process. The general controls provisions of the Act (including good manufacturing practice) apply. |
Explanation: In a traditional 510(k), particularly one from 1998, the "acceptance criteria" are implied by the performance of the predicate devices. The manufacturer's burden is to demonstrate that their new device performs as well as or in a similar manner to the legally marketed predicate devices for its intended use. There isn't a quantitative "performance" metric in the sense of accuracy, sensitivity, or specificity presented, because it's not a diagnostic AI/ML device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a performance study for this type of device. There isn't a "test set" of patient data in the way you'd consider for an AI model. The "test" here is the comparison of technological characteristics and intended use to existing devices.
- Data Provenance: Not applicable. The "data" considered is the design, materials, and intended use of the OAC and its predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: Not applicable. There was no "ground truth" to establish for a test set of patient data. The regulatory body (FDA) reviews the technical specifications and comparisons provided by the manufacturer.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No test set of patient data requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study Status: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or documented in this summary.
- Effect Size: Not applicable, as no MRMC study was conducted.
Explanation: MRMC studies are typical for evaluating the impact of AI algorithms on human reader performance, especially in diagnostic imaging. This device is a manual surgical instrument, not an AI/ML diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Standalone Study Status: No, a standalone performance study (algorithm only) was not done.
- Explanation: This device is a manual medical instrument that requires human operation. It is not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. No "ground truth" in terms of clinical outcomes, pathology, or expert consensus on a dataset was used for this submission. The "ground truth" for a 510(k) of this type is essentially the known safe and effective performance of the predicate devices.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. There is no AI/ML algorithm involved, so no training set was used.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable. No AI/ML algorithm or training set.
Summary of the 510(k) Approach for this Device:
This 510(k) submission relies entirely on substantial equivalence. The manufacturer argues that:
- The OAC curette component is similar to the Milex and Pipelle curettes.
- The OAC hysteroscope component is similar to Imagyn's MicroSpan Hysteroscope.
- Because the components are similar to already-cleared predicate devices, and the intended use is consistent with those predicates ("visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation"), the OAC should also be considered safe and effective.
The FDA's clearance letter confirms their determination of "substantial equivalence" based on this argument, meaning the device can proceed to market without new clinical performance studies demonstrating novel safety or effectiveness.
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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
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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
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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
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INDICATION FOR USE FORM
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| 510 (k) Number (if known): | K980096 | ||||
| Device Name: | Optical Aspirating Curette |
Indications for Use:
:
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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
§ 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.