The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.

Device Description

The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.

AI/ML Overview

This is a 510(k) summary for a Disposable Vaginal Speculum, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for AI/ML performance is not applicable.

The document describes a traditional medical device and its substantial equivalence to a predicate device based on material, intended use, and mechanical/biocompatibility safety testing.

Here's a breakdown of the relevant information provided for this device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Safety	Complies with standard YY0336-2002, Disposable Vaginal Speculum.
Environmental Safety	Complies with standard YY0336-2002, Disposable Vaginal Speculum.
Biocompatibility (Cytotoxicity)	Complies with ISO 10993-5, Biological Evaluation for Medical Devices, tests for Cytotoxicity.
Biocompatibility (Irritation)	Complies with ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hypersensitivity.
Biocompatibility (Hypersensitivity)	Complies with ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hypersensitivity.

2. Sample size used for the test set and the data provenance:

Not applicable. This is a physical medical device, and the evaluation relies on compliance with established consensus standards for mechanical properties and biocompatibility, rather than a "test set" of data in the context of AI/ML.
The document implies that the tests were performed by, or on behalf of, Kunshan Deyi Plastic Co., Ltd., which is a manufacturer in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the AI/ML sense is not relevant for this type of device submission. The "ground truth" here is compliance with material, design, and performance standards as determined through laboratory testing.

4. Adjudication method for the test set:

Not applicable. There is no "adjudication method" described as would be for an AI/ML system's output. Compliance is determined by the results of the specified tests against the criteria in the standards.

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 not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

For mechanical and environmental safety: Compliance with the specified performance requirements within the standard YY0336-2002 (Disposable Vaginal Speculum).
For biocompatibility: Absence of cytotoxicity, irritation, or delayed type hypersensitivity reactions as determined by the methods and criteria in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

Not applicable. There is no training set for a physical, non-AI medical device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K092870

510(k) Summary

FEB 1 6 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 18, 2009

Company and Correspondent making the submission:

Name - Kunshan Deyi Plastic Co., Ltd.

Address - No. 270, Zhongjie Road. Shipu Street,

Qiandeng Town, Kunshan City

Jiangsu Province China

Telephone -- +86-512-57408271

Fax -- +86-512-57408644

Contact – Mr. Alan Zhou

Email - jacky_chen@deyiplastic.com

Device :

Trade/proprietary name: Disposable Vaginal Speculum

: Vaginal Speculum Common Name

Classification Name : speculum, vaginal, nonmetal

Predicate Device:

PredicateModel	Manufacturer	K Number	Submitted Device
Non-sterileDISPOSABLEVAGINALSPECULUM	ZHEJIANGGONGDONGDEDICAL PLASTICFACTORY	K050887	Non-sterile DISPOSABLEVAGINAL SPECULUM

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3. Classifications Names & Citations :

21CFR 884.4530, HIB, Speculum, Vaginal, Nonmetal

4. Product description :

The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.

1. List of sizes and specifications :

Material	Model	BottomDiameter(d: mm)	Mouth Diameter(d: mm)	Height (H;MM)
PS	Small	90	30	90
	Medium	100	38	110
	Large	118	45	115

Image /page/1/Figure/6 description: The image shows a technical drawing of a medical device, possibly a speculum. The drawing includes two views of the device, a side view and a front view. The side view shows the device's overall shape and the adjustable components, labeled as 1 and 2. The front view provides a more detailed look at the device's structure and internal mechanisms.

ਸ਼ਹਿ

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Indication for use :

Comparison with predicate device : (see table next page)

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Comparison Table

Element of comparison	Subject Device	Claimed SE Device
Company	KUNSHAN DEYI PLASTIC CO., LTD.	ZHEJIANG GONGDONG DEDICAL PLASTIC FACTROY
FDA510(K) Number	N/A	K050887
Device Name	Non-sterile DISPOSABLE VAGINALSPECULUM	Non-sterile DISPOSABLE VAGINAL SPECULUM
intended use(s)	Same	The Non-sterile DISPOSABLE VAGINAL SPECULUM is non-sterile products andis intended to be used by a medical professional to expose the interior of thevagina to facilitate visualization during the obstetrical and gynecologicalprocedures.
Production method	Same	injection molding
Material of construction	Same	Polyrex PG-33
View	Same	Providing clear plastic for viewing
Lateral wall protector	Same	Rests in the lateral wall protector affording less chance of interfering with viewof the vagina during proceduresHand operated, multi-position;
Performance	Same	Constructionally equivalent to the cooper speculum which has already beensubjected to millions of applications;
Hand held and manually operated?	Yes	Yes
Heat to escape	Same	Has windows/Vent that allow heat to escape
Assembly	Same	Doesn't require assembly
Hand held and manually operated?	Yes	Yes
Design	Same	Dual, biparting blades
Single Use?	Yes	Yes
Sterile status	Non-sterile	Non-sterile
Mechanical safety	Same	Simple thumb adjustable lever action
Lubrication	Same	Non-Lubricated
Packaging	Same	Bulk pack 10/Plastic Bag, and Individually wrapped
Biocompatibility	Same	Complying with ISO10993
Anatomical sites	Same	Vaginal canal
Human Factors	Same	Single handed use, Self-locks in open position

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Compatibility with the environment	Same	Disposable
Compatibility with the other devices	Same	Compatible with various spatula, Cyto brushes, packing forceps, sound and tenaculum, Tischler Bioposy forceps, scrapers, swabs and probes
Where used?	Same	By a physician; Professional medical facilities or office/clinical examination rooms

. . . . .

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1. Safety and Performance Data :
  Mechanical, environmental safety and performance testing have been accomplished according to standards YY0336-2002, Disposable Vaginal Speculum; ISO 10993-5 , Biological Evaluation for Medical Devices, tests for Cytotoxicicy; ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hyper sensitivity.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Kunshan Deyi Plastic Co., Ltd. concludes that the disposable vaginal speculum is safe and effective and substantially equivalent to predicate devices as described herein.

Kunshan Deyi Plastic Co., Ltd. will update and include in a summary any other 10. information deemed seasonably necessary by the FDA.
END

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Kunshan Devi Plastic Co., Ltd. % Mr. Charles Mack, PE Principal Engineer International Regulatory Consultants 77325 Joyce Way ECHO OR 97826

FEB 1 6 2010

Re: K092870

Trade/Device Name: Disposable Vaginal Speculum Regulation Number: 21 CFR §884.4530 Regulation Name: Vaginal Speculum, non-metal Regulatory Class: II Product Code: HIB Dated: January 26, 2010 Received: February 1, 2010

Dear Mr. Mack:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameridments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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Page 2 -

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting 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): _ K 092870

Device Name: Disposable Vaginal Speculum

Indications for Use: .

The disposable vaginal speculum is a non-sterile product and is intended to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Súbpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Heidi D. Seum

Page Page of

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.