(56 days)
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Not Found
No
The device description and intended use are purely mechanical, describing a physical brush for cell collection. There is no mention of any software, algorithms, or data processing that would suggest AI/ML.
No.
This device is intended for the collection of cervical cells for diagnostic analysis (Pap smear methods and/or STD detection methods), not for treating a disease or medical condition.
No
Explanation: The device is intended for the collection of cervical cells. It is not used to analyze or interpret data to diagnose a disease, but rather to collect samples for analysis in a laboratory.
No
The device description clearly details a physical brush with a handle and bristles, indicating it is a hardware device for collecting cervical cells. There is no mention of software as the primary or sole component.
Based on the provided information, the Cervex-Brush Combi is not an In Vitro Diagnostic (IVD).
Here's why:
- It's a collection device: The description clearly states its purpose is to collect cervical cells. It is a tool used to obtain a sample.
- The analysis happens elsewhere: The collected cells are then sent to a laboratory for analysis by Pap smear methods and/or STD detection methods. The Cervex-Brush Combi itself does not perform the diagnostic test.
- IVDs perform the diagnostic test: IVDs are devices, reagents, or systems intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cervex-Brush Combi does not perform this examination or provide diagnostic information.
Think of it this way: The Cervex-Brush Combi is like a swab used to collect a throat culture. The swab is a collection device, but the diagnostic test (identifying the bacteria) is performed in the lab using other methods.
Therefore, the Cervex-Brush Combi is a specimen collection device, not an IVD.
N/A
Intended Use / Indications for Use
The Rovers Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Rovers Cervex-Brush Combi is not intended for use in pregnant women.
Product codes
85 HHT
Device Description
This device consists of handle with a multi-bristled, soft plastic brush mounted on it. The bristles are intended to collect cervical cells for testing and evaluation. For the middle part of the Cervex-Brush Combi the cell-collecting ability of the device is comprised of substantially eccentrically placed parallel plastic bristles, forming a brush head that is connected to the handle. The eccentrically placed bristles are positioned on opposite sides of a square base. The top of the brush is rounded. Digital rotation with gentle pressure by way of the handle causes to scrape and remove cytological material simultaneously from the ectocervix and the endocervix. Because the bristles are plastic, wet or humid cells are not absorbed so that the cytological material can easily be transferred to a glass slide or a preservative fluid and sent to the laboratory for evaluation. The device is offered sterile and nonsterile. The Cervex-Brush Combi head is composed of polyethylene, the same material that is used for the Cervex- Brush.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
0
Image /page/0/Picture/0 description: The image shows the logo for Rovers Medical Devices BV. The logo features the word "ROVERS" at the top and "MEDICAL DEVICES BV" at the bottom. In the center is a stylized letter "R" inside of a rounded square.
FEB - 2 2005510(k) Summary premarket notification # K043369
Date Submitter's Name, Address, Telephone Number, Contact Person and Prepared
Submitter: Rovers Medical Devices BV Lekstraat 10 5347 KV OSS The Netherlands Phone: +31 (0)412 64 88 70 Fax: +31 (0)412 62 38 35
Contact Person: Mr. M.D. Zwart, Managing Director Rovers Medical Devices B.V.
Device Name
Proprietary Name: Cervex-Brush Combi Common / Usual Name: Cervical Cell Scraper Classification Name: Cervical Cytological Endocervical Brush
Equivalent Device
EndoCervex-Brush, also manufactured by Rovers Medical Cervex-Brush®, Devices BV
Device Description
This device consists of handle with a multi-bristled, soft plastic brush mounted on it. The bristles are intended to collect cervical cells for testing and evaluation. For the middle part of the Cervex-Brush Combi the cell-collecting ability of the device is comprised of substantially eccentrically placed parallel plastic bristles, forming a brush head that is connected to the handle. The eccentrically placed bristles are positioned on opposite sides of a square base. The top of the brush is rounded.
ROVERS MEDICAL DEVICES BV Lekstraat 10 5347 KV Oss The Netherlands Telefoon +31 (0)412 64 88 70 +31 (0)412 62 38 35 Fax info@roversmedicaldevices.com E-mail Internet www.roversmedicaldevices.com
C.o.C. nr 16089473 Bank : ING Bank Oss Account nr. 6552.88.716 VAT-nr. NL806793119B01
Image /page/0/Picture/13 description: The image is a logo with the text "TUV CERT" stacked on top of each other. There are two curved lines above the text. Below the text is the phrase "DIN EN ISO 9001:2000 QA 04100 19877661".
Image /page/0/Picture/14 description: The image shows a logo with the text "RWTUV" in bold, stylized letters. Below the logo, the text "DIN EN ISO 13485" is printed in a smaller, sans-serif font. The entire logo is enclosed within a rounded rectangle with a dashed border, and there is a curved line above the RWTUV text.
1
Digital rotation with gentle pressure by way of the handle causes to scrape and remove cytological material simultaneously from the ectocervix and the endocervix. Because the bristles are plastic, wet or humid cells are not absorbed so that the cytological material can easily be transferred to a glass slide or a preservative fluid and sent to the laboratory for evaluation. The device is offered sterile and nonsterile. The Cervex-Brush Combi head is composed of polyethylene, the same material that is used for the Cervex- Brush.
Intended Use Statement
The Rovers Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Rovers Cervex-Brush Combi is not intended for use in pregnant women.
Technological Characteristics and Substantial Equivalence
The Cervex-Brush Combi is substantially equivalent in terms of intended use, design, manufacturing processes, physical properties, and principles of operation to the Cervex-Brush® and EndoCervex-Brush.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2005
Mr. Ir. M.D. Zwart Managing Director Rovers Medical Devices B.V. Lekstraat 10 5347 KV OSS THE NETHERLANDS
Re: K043369 Trade/Device Name: Cervex-Brush Combi Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HHT Dated: December 6, 2004 Received: December 8, 2004
Dear Mr. Zwart:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) rins retet notification. The FDA finding of substantial equivalence of your device to a legally promaticated predicated on " results in a classification 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 don't bpoille at need 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 premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77 . - 1 canall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
4
Image /page/4/Picture/0 description: The image shows the logo for Rovers Medical Devices BV. The logo consists of a large, stylized letter "R" inside a square. The text "ROVERS" is above the square, and "MEDICAL DEVICES BV" is below the square.
Indications for Use
510(k) Number (if known): K043369
Device Name:
Cervex-Brush Combi
Indications for Use:
The Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Cervex-Brush Combi is not intended for use in pregnant women.
Prescription Use V (Part 21 CFR 801 Subpart D)
ANDTOR
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 R. Ingram
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, Division of Ropal Devices
510(k) Number. ROVERS MEDICAL DEVICES BV Lekstraat 10 5347 KV Oss The Netherlands Telefoon +31 (0)4126488 70 +31 (0)412 62 38 35 Fax info@roversmedicaldevices.com E-mail Internet www.roversmedicaldevices.com
C.o.C. nr 16089473 Bank: ING Bank Oss Account nr. 6552.88.716 VAT-nr. NL806793119B01
Image /page/4/Picture/16 description: The image shows two logos and the text "Page 1 of 1". The logo on the left has the text "TUV CERT" and "Din EN ISO 9001:2000 QA 04100 16877981". The logo on the right has the text "RWTUV" and "DIN EN ISO 13485". Both logos are inside a rounded rectangle.