(59 days)
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No
The summary describes a basic mechanical device (vaginal speculum) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device, a vaginal speculum, is used for diagnostic or examination purposes (to expose the cervix for general vaginal operation), not for treating a disease or condition.
No
The device is a speculum, used for exposure, not for diagnosis. Its intended use describes it as an instrument for "general vaginal operation" to "expose the cervix," which facilitates visual inspection or other procedures, but does not perform a diagnostic function itself.
No
The device is described as a "Vaginal Speculum," which is a physical instrument used for medical procedures. The description does not mention any software components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a "general vaginal operation in which it is inserted into the vagina to expose the cervix." This describes a physical instrument used for examination or procedure within the body.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The description of the vaginal speculum does not involve the analysis of any biological samples.
Therefore, the Global Healthcare's Vaginal Speculum is a medical device, but it falls under the category of a surgical or examination instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Global Healthcare's Vaginal Speculum is intended to be used for general diagnostic examination of vaginal operation in medicine and medical science. It is inserted into the vagina to expose the cervix.
Product codes
85 HIB
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
vagina, cervix
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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.
1
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
2
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