The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.

Device Description

This device consists of a reusable handle and a multi-component assembly. The reusable handle provides a means of expanding and manipulating the CerCol™ Cervical Sample Collector so that the surface areas of the endo-cervix, ecto-cervix and transition zones of the cervix are completely contacted by the CerCol™ Cervical Sample Collector tip for the collection, transport, analysis and testing of exfoliated cervical epithelial cells. The CerCol™ Cervical Sample Collector will be available as a single use, non-sterile disposable device and the reusable handle will be available separately, but both components must be used together as part of the CerCol™ Cervical Sample Collector System.

AI/ML Overview

The document K062433 describes the Diamics CerCol™ Cervical Sample Collection System, a device intended for the collection of cervical cytology material for Pap analysis. The submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily evaluates substantial equivalence based on the ability of the device to collect satisfactory cervical samples, indicated by the rate of satisfactory results and the presence of endocervical/transformation zone components, which are crucial for effective Pap testing.

Acceptance Criterion	Target / Predicate Performance (based on MedScand Sample Collection Kit)	Reported Device Performance (Diamics CerCol™ Cervical Sample Collector)	Meets Criteria?
Satisfactory Sample Rate (Clinical Study 1)	99.6%	98.9%	Yes
Satisfactory Sample Rate (Clinical Study 2)	Not applicable (standalone CerCol study)	99.0%	Yes
Endocervical/Transformation Zone Component	Not explicitly stated for predicate in this context	98.0% (Clinical Study 2)	Yes
Biocompatibility	Deemed safe for intended use	Determined to be safe for intended use	Yes
Mechanical Performance (Expansion/Retraction)	Expected and adequate	Performs as expected and adequate	Yes
Conformance & Coverage	Expected	Performs as expected	Yes

Note: The acceptance criteria are largely implied by demonstrating clinical performance comparable to the predicate device and by meeting pre-defined parameters in bench testing. Numerical targets are primarily derived from the predicate's performance or internal benchmarks for mechanical aspects.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Study 1:
- Test Set Size: 265 standard (predicate device) collections and 265 CerCol™ Cervical Sample Collections.
- Data Provenance: Pooled across two centers. No country of origin is explicitly mentioned, but typically for FDA submissions, studies are conducted in the US or in countries with comparable medical standards. The study appears to be prospective or concurrent as it compares two collection methods simultaneously.
Clinical Study 2:
- Test Set Size: 102 CerCol™ Cervical Sample Collector collections.
- Data Provenance: Conducted at one center. No country of origin is explicitly mentioned. This study also appears to be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for interpreting the Pap analysis results. It refers to "satisfactory results" and "endocervical/transformation zone component," which would typically be determined by trained cytotechnologists and/or pathologists. However, the specific details about these experts are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It only mentions that the studies resulted in "satisfactory results," implying that the assessment of sample quality was done according to established laboratory protocols.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The studies described are clinical studies comparing the sample collection efficacy of the device to a predicate device, focusing on the quality of the collected sample rather than the diagnostic accuracy improvement of human readers with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This is a medical device for sample collection, not an AI or algorithm-based diagnostic tool. Therefore, a standalone algorithm-only performance study is not applicable to this device. The "Performance Data" section primarily addresses mechanical bench testing of the device components.

7. The Type of Ground Truth Used

The ground truth used in the clinical studies is based on the assessment of sample adequacy for Pap analysis. This includes:

Satisfactory Result: Indicating that the collected sample is sufficient for cytological examination.
Presence of Endocervical/Transformation Zone (EC/TZ) Component: Cytological evidence showing that cells from this critical area of the cervix (where most cervical cancers originate) have been collected. This assessment is typically made by trained laboratory personnel (cytotechnologists/pathologists) based on microscopic examination of the prepared slides.

8. The Sample Size for the Training Set

This document only describes performance and clinical studies for a medical device that collects samples. It does not describe an AI or machine learning model, so there is no "training set" in the context of AI. The "manufacturing process" section mentions Quality Control (QC) tests performed on 100% of manufactured devices, which could be considered an internal quality assurance process but not a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no AI/ML model described, there is no "training set" and thus no ground truth established for it in this document.

Summary

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K06 2433

MAR 1 6 2007

510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Date Prepared:	August 15, 2006
Applicant:	Diamics Incorporated 6 Hamilton Landing, Suite 200 Novato, California 94949 PH (415) 883-0414 FAX (415) 883-0415
Contact Person:	Peter Gombrich, Chief Executive Officer and Chairman
Trade Name:	Diamics CerCol™ Cervical Sample Collection System
Common Name:	Cervical Cytological Sample Collector
Classification Name:	Collector, Cervical Cytological
Classification Status:	CFR 884.4530
Device Classification:	II
Product Code:	HHT
Predicate Device:	MedScand Sample Collection Kit, Cytyc Part # 70124-001, consisting of the Pap Perfect® Plastic Spatula (K832986) and the Cytobrush® Plus GT Gentle Touch (K861389)

Substantially Equivalent To: The Diamics, Inc. CerCol™ Cervical Sample Collector system,
is equivalent to the MedScand Sample Collection Kit, Cytyc Part

70124-001, consisting of the Pap Perfect® Plastic Spatula

(K832986) and the Cytobrush® Plus GT Gentle Touch
(K861389)#### Description of the Device Subject to Premarket Notification:

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Indications for Use:

The Indications for Use for the Diamics CerCol™ Cervical Sample Collector System has the same intended use and similar technological characteristics in sampling of cervical tissue as compared to the predicate device, the MedScand Sample Collection Kit, Cytyc Part # 70124-001, consisting of the Pap Perfect® Plastic Spatula and Cytobrush® Plus GT Gentle Touch. No new questions of safety or efficacy are raised and information is provided in this submission to demonstrate the safety and efficacy of the devices.

Technical Characteristics:

The CerCol™ Cervical Sample Collector and the predicate device, Cytobrush Plus GT Gentle Touch, are designed to collect and transport exfoliated cervical cells for Pap analysis. The predicate device and the CerCol™ Cervical Sample Collector device in this premarket notification are similar in that both devices are manually manipulated by the hand of the clinician or physician to collect cervical cells. Neither the predicate device nor the Diamics CerCol™ Cervical Sample Collector device is recommended for use in pregnant women.

The predicate device consists of a brush with bristles of various lengths, designed to randomly collect cells from the contours of the cervix. The middle and longest bristles of the predicate device reach deep into the endocervical canal and the shorter bristles touch both the ectocervical and transition zone.

The CerCol™ Cervical Sample Collector is designed with an elastomer tip that conforms to the endocervical canal, and collects cells from the endocervix, the ectocervix and the transition zone. The predicate device is rotated five times by the CerCol™ Cervical Sample Collector is designed to be rotated slightly to thirty degrees by the user.

Once the sample has been collected with the predicate device, the specimen is prepared for laboratory analysis. The sample may be transferred to a slide by rubbing the brush over the surface of the slide. Or, the sample may be transferred to a vial containing liquid preservative by either breaking the brush head off into a preservative vial. In a similar manner, the sample is transferred from the CerCol™ Cervical Sample Collector for analysis by immersing the Collector tip into a similar vial of liquid preservative. Despite the minor differences in collection and transfer of the samples to liquid preservative, the devices are equivalent.

The materials used to manufacture both devices have been tested for biocompatibility and have been determined to be safe for their intended use. No chemicals are used to manufacture the Diamics CerCol™ Cervical Sample Collector device that is subject of this premarket notification.

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Performance Data:

Performance testing (bench testing) was performed for the CerCol™ Cervical Sample Collector system to assure that it performs within the predefined parameters. The expansion and retraction action of the handle's tip performs as expected and is adequate for its intended use. Performance testing has been documented, validated and the handle performs as intended and to its specifications.

The expansion of the disposable collector's elastomer tip, the conformance of the expanded tip inside the mock cervix, and the three hundred sixty degree coverage of the endocervical, ectocervical and transition zone performs as expected. Performance testing has been documented, validated and the disposable collector performs as intended and to its specifications.

The CerCol™ Cervical Sample Collector is manufactured under controlled processes. During the manufacturing process, Quality Control (QC) tests are performed. The QC tests are performed on 100% of the CerCol™ Cervical Sample Collector devices as they travel through the production process. A Device History Record (DHR) form is maintained for each lot that is produced.

Basis For Determination of Substantial Equivalence:

The CerCol™ Cervical Sample Collection system manufactured by Diamics Inc. is substantially equivalent to the MedScand Sample Collection Kit. Cytyc Part # 70124-001, consisting of the Pap Perfect® Plastic Spatula and Cytobrush® Plus GT Gentle Touch. Substantial equivalence is based upon the fact that these devices have the same intended uses and similar principles of operation. Substantial equivalence is also based on the fact that the clinical data results demonstrate performance of the subject device is substantially equivalent to the MedScand Sample Collection Kit, Cytyc Part # 70124-001, consisting of the Pap Perfect® Plastic Spatula and Cytobrush® Plus GT Gentle Touch the predicate device.

The clinical data were pooled across two centers resulting in 265 standard collections with 251 satisfactory results and 265 CerCol™ Cervical Sample Collections with 251 satisfactory results. The observed rate of satisfactory for the standard method is 99.6% and the observed rate of satisfactory for the CerCol™ Cervical Sample Collector is 98.9%.

Another clinical study, at one center, resulted in 102 CerCol™ Cervical Sample Collector collections with 101 satisfactory results, 99 of which contained endocervical/transformation zone component. The observed rate of satisfactory for the CerCol™ Cervical Sample Collector in this study was 99.0 % and the observed rate of endocervical/transformation zone component was 98.0 %.

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Maureen Mende Director, Regulatory Affairs and Quality Assurance Diamics, Inc. Six Hamilton Landing, Suite 200 NOVATO CA 94949

MAR 1 6

Re: K062433

Trade/Device Name: Diamics CerCol" Cervical Sample Collector Regulation Number: 21 CFR §884.4530 (a)(13) Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HHT Dated: March 6, 2007 Received: March 8, 2007

Dear Ms. Mende:

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.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The words "FDA Centennial" are written in the center of the logo. There are stars and other text surrounding the central image.

Protesting and Promoting Public Health

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 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 premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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Indications for Use Statement

510(k) Number (if known):	K062433
Device Name:	Diamics CerCol™ Cervical Sample Collector
Indications for Use:	The Diamics CerCol Cervical Sample Collector is indicatedfor the collection of cervical cytology material and itstransfer for Pap analysis. The Diamics CerCol CervicalSample Collector is not intended for use in pregnantwomen.

Prescription Use: X (Part 21 CFR 801 Subpart D)

....

And/OR

Over-the-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Nancy C. Bardon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K062433

A BRAND A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAT A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEACH A BEAC

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.