(177 days)
The FemSpec disposable vaginal speculum is indicated for diagnostic procedures of the cervix.
The FemSpec disposable vaginal speculum consists of a soft plastic inflatable bladder, which once inserted into the vagina is inflated to uniformly press the vaginal wall open. Once inflated the bladder generates an annular space for diagnostic procedures of the cervix.
The provided text is a 510(k) summary for the FemSpec Disposable Vaginal Speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information from the given text. The FDA 510(k) summary is generally a declaration of substantial equivalence, and while it references testing that would have occurred, it does not explicitly detail the acceptance criteria or study results for performance.
To answer your request, I would need a different document, such as a test report, a clinical study summary, or a more detailed performance evaluation report that specifies acceptance criteria and observed performance.
Here's what I can extract from the provided text based on your prompt, explaining why certain sections are not applicable:
-
A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not define specific acceptance criteria (e.g., specific thresholds for mechanical strength, inflation time, or viewing area) nor does it report detailed device performance metrics against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
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Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. The document does not describe a clinical or performance test set, sample size, or data provenance.
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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. No ground truth establishment is described as there is no performance test set detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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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 device is a physical medical instrument (a vaginal speculum), not an AI-powered diagnostic system. Therefore, an MRMC study or AI-related metrics are irrelevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As noted above, this is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth is mentioned. The device's function is to provide access for diagnostic procedures, not to perform a diagnosis itself that would require ground truth comparison for its own performance.
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The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning algorithm. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth for it.
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DEC 2 3 2004
K041757
SECTION V:
| 510(k) Summary FemSpec Disposable Vaginal Speculum | |||
|---|---|---|---|
| Date Prepared: | |||
| This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. | |||
| A. | Submitter | FemSpec220 Halleck Street, Suite 120San Francisco, CA 94129-0450 | |
| B. | Company Contact | Gerald Jay Sanders, CEO | |
| C. | Device Name | ||
| Trade Name: | FemSpec Disposable Vaginal Speculum | ||
| Common Name: | Disposable Vaginal Speculum | ||
| Classification Name: | Non-metal Vaginal Speculum | ||
| Classification: | Class II per 21 CFR 884.4530 | ||
| D. | Predicate Devices | K012535 - Doctors Research Group SoftSpec Vaginal Speculum | |
| E. Description of Device | |||
| The FemSpec disposable vaginal speculum consists of a soft plastic inflatable bladder, which once inserted into the vagina is inflated to uniformly press the vaginal wall open. Once inflated the bladder generates an annular space for diagnostic procedures of the cervix. | |||
| D. | Intended Use | ||
| The FemSpec disposable vaginal speculum is indicated for diagnostic procedures of the cervix. | |||
| E. Comparison of Technological Characteristics | |||
| The basic technology, design, mode of operation, materials of construction and intended use of the FemSpec™ disposable vaginal speculum is substantially equivalent to the predicate device. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
Mr. Gerald Jay Sanders CEO FemSpec L.L.C. 220 Halleck Street, Suite 120B P.O. Box 29450 SAN FRANCISCO CA 94129 Re: K041757 Trade/Device Name: FemSpec™ Disposable Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: October 19, 2004 Received: October 20, 2004
Dear Mr. Sanders:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your bettred by to substantially equivalent (for the indications for use stated in above and have detenimined the ad predicate devices marketed in interstate commerce prior to the cliciosate) to tegans mantelou promises province Amendments, or to devices that have been May 26, 1770, die enactified and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondation while proval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act device, subject to the general economy prove, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is olassified (500 as the Additional controls. Existing major regulations affecting your Apploval), it may be sabject to earling the 21, Parts 800 to 898. In addition, FDA device ban of round minouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that r Rase be advisou that i Driver in that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I caral statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, moduling bactice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to ogin mating of substantial equivalence of your device to a legally premarked notification: "The PDF Interiog sification 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 If you desire specific advice tor your derroof the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entires) formation on your responsibilities under the Act from the 807.77). Tou may obtain carees, International and Consumer Assistance at its toll-free number (800) DVNSloll or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmadsmamain.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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: FemSpec™ Disposable Vaginal Speculum
Indications for Use:
The FemSpec™ disposable vaginal speculum is indicated for diagnostic procedures of the cervix.
Prescription Use: X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David W. Lyonn
Abdominal
Page 1 of 1
§ 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.