(471 days)
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Not Found
No
The provided text focuses on the clinical use and benefits of the device as an adjunct to Pap smears, emphasizing improved sensitivity. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the use of AI/ML. The "Not Found" entries for key sections like "Device Description," "Mentions image processing," and "Mentions AI, DNN, or ML" further support this conclusion.
No.
The device is used for screening and diagnosis (identifying mucosal abnormalities), not for treating a condition.
Yes
The device, Speculoscopy, is indicated for cervical screening in women to identify mucosal abnormalities, and its combined use with a Pap smear improves sensitivity in identifying women appropriate for colposcopy or close follow-up. This indicates its use in identifying diseases or conditions.
Unknown
The provided text only describes the intended use and indications for use. It lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Focus on Visualization: The intended use describes "Speculoscopy" and "mucosal abnormalities visualized on colposcopy." This strongly suggests a device that is used to visualize the cervix, rather than analyze a biological sample in vitro (outside the body).
- Adjunct to Pap Smear: The device is described as an "adjunct to the Pap smear." The Pap smear is an IVD, as it involves the laboratory analysis of cervical cells. The Speculoscopy device appears to be used in conjunction with the Pap smear, likely during the pelvic examination, to provide additional visual information.
- No Mention of Sample Analysis: There is no mention of collecting or analyzing a biological sample (like blood, urine, or tissue) by the device itself. The focus is on the visual examination.
In summary, the description points towards a device used for visual examination of the cervix during a clinical procedure, which is not the typical function of an In Vitro Diagnostic device. IVDs are primarily used for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
- Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear.
- Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy.
- The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.
Product codes
85 MPU
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 12 1997
Martin L. Lonky, Ph.D. President, CEO The TRYLON Corporation 970 West 190th Street, Suite 850 Torrance, California 90502-1037 Re: K963391 Speculite®/Speculoscopy Dated: July 28, 1997 Received: July 31, 1997 Regulatory class: II 21 CFR §884.4530/Product code: 85 MPU
Dear Dr. Lonky:
We have reviewed your Section 5100k) 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, subject to the general controls provisions of 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 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 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 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 marked 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 Complance 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.Liau Yu
Lillian Xin, Ph.D.
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
1
Appendix F, Attachment 3.0 Indications for Use Statement
Image /page/1/Picture/4 description: The image is a black and white logo. The logo is a circle with the word "TRION" written across the top. In the center of the circle is a black, diamond-shaped figure. The diamond shape is textured with many small dots.
The TRYIQN Corporation
970 West 190th Street, Suite 900, Torrance, CA 90502-1037
(310) 327-8820 FAX (310) 327-8979
Revised 12/12/97 510(K) 963391: Device Name: Speculite Indications for Use:
- Speculoscopy is indicated for use in those women who are currently recommended for ♪ . cervical screening with pelvic examination and Pap smear.
- Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of ♪ the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy.
- The combined results of the Pap smear with Speculoscopy in the screening examination, ♪ designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K963391 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------ | --------------------------------------------------------------------------- | ---- | ---------------------- | -- |