The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods. It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.

Device Description

The Disposable Cervical Brush is a non-sterile, disposable, colored cytological cervical spatula intended for collecting cytological materials from the surface of the cervix. This device consists of two components: a white colored head and a pink colored handle. The head contains a brush and a connection portion. The head and handle are physically connected through a male/female connection mechanism. The handle is made of Polypropylene (PP) and the head is made of low density polyethylene (LDPE). This device has a 3-years shelf-life.

AI/ML Overview

The provided documentation is a 510(k) summary for a Disposable Cervical Brush, a medical device used for collecting cervical cells for Pap smear analysis. It outlines the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating safety and performance through non-clinical testing and comparison to a predicate device. The underlying acceptance criterion for a 510(k) is substantial equivalence to a predicate device, meaning it is as safe and effective as the legally marketed predicate.

The reported performance is primarily derived from meeting established standards for biocompatibility and mechanical integrity, which implicitly demonstrate that the device performs as intended and is safe for its intended use.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Biocompatibility	Cytotoxicity	Conducted and passed
	Vaginal irritation	Conducted and passed
	Guinea Pig Maximization Sensitization	Conducted and passed
Mechanical Performance	Brush off test	Conducted and passed
	Joint strength (firm connection) test	Conducted and passed
	Bending strength resistance test	Conducted and passed
	Tensile strength at the bristle joint test	Conducted and passed
	Tensile strength at connection portion of the brush head test	Conducted and passed
Chemistry	Reduction material test	Conducted and passed
	Heavy metals test	Conducted and passed
	Cadmium test	Conducted and passed
	pH value test	Conducted and passed
	Dissolution tests of brush head and brush handle	Conducted and passed
Substantial Equivalence	Intended Use	Same as predicate (K896065)
	Structure	Same as predicate
	Materials	Same as predicate
	Dimensions	Comparable to predicate (minor differences not raising concerns)
	Color	Same as predicate

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes non-clinical (bench) testing for biocompatibility, mechanical performance, and chemistry. It does not mention a "test set" in the context of clinical data, as it's a 510(k) for a Class II manual instrument where clinical studies are often not required if substantial equivalence can be demonstrated through other means.
- For the non-clinical tests, specific sample sizes are not provided, nor is the country of origin of the testing data or whether it was retrospective or prospective. It is implied these were prospective tests conducted to evaluate the device.
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. The document describes non-clinical testing, not a study involving expert-established ground truth on patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving adjudication of human-interpreted data.
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/software device, and no MRMC study is mentioned. The device is a manual instrument for cell collection.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference standards were established laboratory testing standards and methods for biocompatibility, mechanical properties, and chemical composition. For instance, cytotoxicity tests adhere to recognized protocols to determine the biological response.
The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.
How the ground truth for the training set was established
- Not applicable. As there's no training set, there's no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three interconnected human profiles facing to the right.

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

May 14, 2015

Ningbo HLS Medical Products Co., Ltd % Leon Lu Director of Quality and Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway Dover, DE 19901

Re: K141057

Trade/Device Name: Disposable Cervical Brush Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HHT Dated: March 18. 2015 Received: April 13, 2015

Dear Leon Lu,

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 Amendments, 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 (reporting of medical device

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related 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141057

Device Name

Disposable Cervical Brush

Indications for Use (Describe)

The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods.

It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

Date of Preparation: 05/13/2015

510(k) Owner:

Ningbo HLS Medical Products Co., Ltd No.801, Changxing Road, Changhe Town Cixi City, Ningbo, Zhejiang, China

Correspondent:

Di Wu Requlatory Affairs Specialist MEDevice China, Ltd. 12F Weiya Building, No.29 Suzhou Street, Haidian District Beijing, China 100080 Email: info@medevicechina.com www.medevicechina.com Tel: +086-10-57846520

Device Information:

Trade name: Disposable Cervical Brush Classification name: Obstetric-Gynecologic Specialized Manual Instrument (21 CFR 884.4530) Requlation class: II Product Code: HHT (Spatula, Cervical, Cytological)

Predicate Device:

Wallach CC/Brush (K896065)

Device Description:

Indications for Use:

The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods.

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lt is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.

Non-Clinical Tests Performed:

The following biocompatibility testing was conducted on this device to ensure safety:

. Cytotoxicity
Vaginal irritation ●
Guinea Pig Maximization Sensitization

The following mechanical testing was conducted on this device to ensure performance:

Brush off test
Joint strength (firm connection) test ●
Bending strength resistance test ●
Tensile strength at the bristle joint test ●
Tensile strength at connection portion of the brush head test ●

The following chemistry testing was conducted on this device to ensure safety:

Reduction material test ●
Heavy metals test ●
Cadmium test
pH value test ●
Dissolution tests of brush head and brush handle

Predicate Device Comparison:

Category	Subject (K141057)	Predicate (K896065)
Device	Disposable Cervical Brush	Wallach CC/Brush
Intended use	Same as the predicate	To collect the cervical cell specimen
Structure	Same as the predicate	The device consists of a brush head and ahandle. The two parts are joined throughthe connection portion of the head.
Dimensions	Length overall – 208 mmLength of head - 30 mmWidth of brush head – 21 mm	Length overall - 205 mmLength of head - 28 mmWidth of brush head – 19 mm
Materials	Same as the predicate	Head - Low density polyethylene (LDPE)Handle - Polypropylene (PP)
Color	Same as the predicate	Colored

The subject and predicate devices have the same intended use and technological characteristics (design and materials). They also have comparable dimensions. The minor differences in dimensions do not raise any concerns. Thus, the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.

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.