(59 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (vaginal speculum) and contains no mention of AI, ML, image processing, or data analysis.
No
The device is a speculum used to facilitate visualization during medical procedures, not to treat a condition or disease.
No
Explanation: The device, a vaginal speculum, is used to facilitate visualization during procedures. While visualization is a part of diagnosis, the speculum itself does not perform any diagnostic function (e.g., analyze data, produce a diagnostic reading, or interpret findings). It is a tool for exposure, not diagnosis.
No
The device is a physical medical device (vaginal speculum) and the summary does not mention any software component.
Based on the provided information, the YuSheng Disposable Vaginal Speculum is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures." This is a physical tool used for examination and access, not for testing samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
An IVD is a medical device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The vaginal speculum is a tool for physical examination and access, not for performing such tests.
N/A
Intended Use / Indications for Use
The YuSheng Disposable Vaginal Speculum is non sterile products and is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures.
Product codes
HIB
Device Description
YuSheng Disposable Vaginal Speculum
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional
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.
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Image /page/0/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird-like symbol consists of three curved lines that resemble wings or feathers, giving the impression of movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 15 2005
Peifang Xing Zhejiang YuSheng Medical Instrument Co., Ltd. Xuanmen Industrial Zone Lupu Town, YuHuan County Zhejiang Province P. R. CHINA 317608
Re: K052912
Rose Device Name: YuSheng Disposable Vaginal Speculum Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-Gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: October 10, 2005 Received: October 19, 2005
Dear Mr. Xing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 510(t) promation in the indications for use stated in above and have delectimical the devices marketed in interstate commerce prior to the enclosure) to regally marketed productions do readments, or to devices that have been
May 28, 1976, the enactment date of the Medical Device Amend Corporia Ant (Act) the May 28, 1976, the ellacinent uate of the Federal Food, Dug, and Cosmetic Act (Act) that reclassified in accordance with the proval application (PMA). You may, therefore, market the A do not require approval of a prematics approvation (The Scheral controls provisions of the Act
device, subject to the general controls provisions of the Act. The provise prov device, subject to the general controls provinces of the results of the of the practice, labeling, merade requires 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 classince (see above) into states) . Existing major regulations affecting your Approval), if may be subject to such adultions, Title 21, Parts 800 of 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parts 800 nort device can be found in the South of Concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that TDA 's ISSualled of a successments of the Act of the Act of any
FDA has made a determination that your device complies with other requires with all FDA has made a delemination mat your de roo compress from secures. You must comply with all the Federal statues and regulations administered by Chiles - Chicago (2 CFR Part 807); labeling Act s requirements, miciuding, but not minted to registration of think on trallity systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set to provisio (ZT CFR Part 801), good manufacturing product the electronic product radiation control provisions (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 Section 510(k)
. In the same of the support of any to be success of your device to a legal This letter will allow you to begin marketing your antine equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence and thus premarket notification. The FDA Inding of substantial of 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 for your device on our laboring regulation (
contact the Office of Compliance at one of 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 prematice notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other gelleral information on Four September Assistance at its toll-free number (800) DIVIsion of Oman Mass-6597 or at its Internet address 056-2017 Of (3.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Image /page/2/Picture/0 description: The image shows a logo with the letters "YS" in the center of a circle. The letters "YS" are stylized and intertwined. The letters "H" and "11" are located on the top left and right of the circle, respectively. The letter "P" is located at the bottom right of the circle.
.Xuanmen Industrial Zone, Lupu Town Yulluan Zhejiang YuSheng Medical Instrument Co. Ltd. Zhejiang Province, Province, P.R.China. 317608. Email: zjyushengaemail.tzptt.zj.cn Fax: +86-576-7206798 County . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 8
Indications for Use
510(k) Number:
Device Name: YuSheng Disposable Vaginal Speculum
Indications for Use:
The YuSheng Disposable Vaginal Speculum is non sterile products and The YuSheng Disposable vaginal opeofessional to expose the interior
is intended to be used by a medical professional to expose trical and is intended to be used by a medical proressons.
of the vagina to facilitate visualization during the "obstetrical and gynecological procedures.
9
Prescription Use
Derald G. Lyonn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi
510(k) Number K052412