(385 days)
No
The device description and performance studies focus on the physical characteristics and mechanical/biocompatibility testing of a manual cervical brush, with no mention of AI or ML.
No
The device is described as a tool for collecting cervical cells for analysis, not for treating a condition or disease.
No
The device is intended for the collection of cervical cells for analysis by Pap smear methods, which is a sample collection step. It does not perform the analysis or provide a diagnosis itself.
No
The device description clearly outlines physical components (head, handle, brush) made of specific materials (Polypropylene, LDPE) and describes mechanical and chemistry testing, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the collection of cervical cells. It is a tool used to obtain a sample.
- Analysis Method: The collected cells are then analyzed by "Pap smear methods." The device itself does not perform the analysis or provide diagnostic information.
- Device Description: The description focuses on the physical components and materials of the brush, not on any reagents, assays, or analytical capabilities.
- Performance Studies: The performance studies listed are related to the physical and chemical properties of the device (biocompatibility, mechanical strength, chemistry), not to its ability to detect or measure specific analytes or provide diagnostic results.
IVD devices are typically used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) to collect the specimen.
Therefore, the Disposable Cervical Brush is a medical device used for specimen collection, which is a step that precedes an IVD procedure (the Pap smear analysis).
N/A
Intended Use / Indications for Use
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.
Product codes
HHT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician or other qualified health 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
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
Key Metrics
Not Found
Predicate Device(s)
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.
0
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
1
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
2
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) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | |||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |||
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | |||
| of this information collection, including suggestions for reducing this burden, to: | |||
| Department of Health and Human Services | |||
| Food and Drug Administration | |||
| Office of Chief Information Officer | |||
| Paperwork Reduction Act (PRA) Staff | |||
| PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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:
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.
Indications for Use:
The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods.
4
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 a |
| handle. The two parts are joined through | ||
| the connection portion of the head. | ||
| Dimensions | Length overall – 208 mm | |
| Length of head - 30 mm | ||
| Width of brush head – 21 mm | Length overall - 205 mm | |
| Length of head - 28 mm | ||
| Width 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.