(59 days)
The Global Healthcare's Vaginal Speculum is intended to be used for general vaginal operation in which it is inserted into the vagina to expose the cervix.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a Global Healthcare Vaginal Speculum, issued on January 17, 2002. This type of document confirms substantial equivalence to a legally marketed predicate device.
It is important to note that this document is for a medical device (vaginal speculum), not an AI/ML-powered or software-based medical device. Therefore, the detailed acceptance criteria and study information requested (e.g., sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to the traditional medical device approval process reflected here.
The FDA's decision for this device is based on substantial equivalence to existing predicate devices, implying that its safety and effectiveness are similar. The letter does not describe specific performance studies in the way one would for an AI/ML product.
Therefore, I cannot provide a detailed response for the requested sections relevant to AI/ML device studies because the provided document does not contain that information.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance:
Since this is a traditional medical device demonstrating substantial equivalence, there isn't a table of quantitative acceptance criteria and reported device performance in the same way an AI/ML product would have (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on:
| Acceptance Criterion | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use | "The Global Healthcare's Vaginal Speculum is intended to be used for general gynecological examination and vaginal operation. It is inserted into the vagina to expose the cervix." |
| Safety | Considered comparable to legally marketed predicate devices. |
| Effectiveness | Considered comparable to legally marketed predicate devices in performing its intended function. |
| Basic Design & Materials | Similar enough to predicate devices to not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The approval is not based on a clinical trial with a "test set" in the context of an AI/ML model. It relies on a comparison to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. This is not how traditional medical devices are evaluated for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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:
- Not Applicable. This is a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For this traditional device, the "ground truth" is its established function and safety record compared to existing, legally marketed devices.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for a physical medical device.
9. How the ground truth for the training set was established:
- Not Applicable.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines extending from its head, representing human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Alam Ahmed President Global Healthcare 1144 Canton Street STE. 103 ROSWELL GA 30075
Re: K013835
Trade/Device Name: Global Healthcare Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II
Product Code: 85 HIB Dated: November 15, 2001 Received: November 19, 2001
Dear Mr. Ahmed:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booking is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cholosare) to regally comment date of the Medical Device American by D comments with to May 20, 1970, are enames with the provisions of the Federal Food, Drug, devices mark form room roomstiled in assessment of a premarket approval application (PMA). and Costient Act (Act) that do not required to the general controls provisions of the Act. The I ou may, incretore, market the act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (600 a00 regulations affecting your device can be It may of Subjoor to additional constions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I rease of advised that I DT 3 issualite of our device complies with other requirements of the Act that I Dr has made a dolorimiations administered by other Federal agencies. You must of any I oderal statutes and roginements, including, but not limited to: registration and listing Compry with and Hec Frequirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), laooming (21 CFR Part 820); and if applicable, the electronic forth in the quality bybelins (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):__K013835
Device Name:_Global Healthcare Vaginal Speculum
Indications For Use:
The Global Healthcare's Vaginal Speculum is intended to be used for general The Global Healthouro of vaginal operation in is inserted into the vagina to expose the cervix.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 3-10-98)
Narayc bawshn
Division of Reproductive, Abdominat,
and Radiological Devices
510(k) Number K013835
§ 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.