The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.

Device Description

The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure. Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ExCellerator Cervical Collection Device
Purpose: Cervical spatula for collecting ectocervical specimens for ThinPrep Pap test and aiding transfer of endocervical brush specimens.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several types of testing with acceptance criteria.

Biocompatibility Assessments:

Assessment	Test	Acceptance Criteria	Reported Device Performance
Cytotoxicity	MEM Elution Cytotoxicity Assay (ISO)	Non-Cytotoxic	Passed (Non-Cytotoxic)
Irritation	Vaginal Mucosal Irritation Test (ISO)	Non-Irritant	Passed (Non-Irritant)
Sensitivity	Guinea Pig Maximization Test (ISO)	Non-sensitizer	Passed (Non-sensitizer)

Structural Assessments:

Assessment	Test Performed	Acceptance Criteria	Control Mode	Group	Reported Device Performance
Static Bend	Static Cantilever Bend	< 2-3mm Displacement (Bend)	Displacement (Bend)	A (2017 Production Lot)	Passed
Static Bend	Static Cantilever Bend	< 2-3mm Displacement (Bend)	Displacement (Bend)	B (2009 Production Lot)	Passed
Static Tension	Static Tension	< 1mm Deformation	Deformation	A (2017 Production Lot)	Passed
Static Tension	Static Tension	< 1mm Deformation	Deformation	B (2009 Production Lot)	Passed
Static Torsion	Static Torsion	< 45° Angular Displacement	Angular Displacement	A (2017 Production Lot)	Passed
Static Torsion	Static Torsion	< 45° Angular Displacement	Angular Displacement	B (2009 Production Lot)	Passed
Shelf Life	Not explicitly stated	> 7 years	Not explicitly stated	Not explicitly stated	Successfully Assessed

Dimensional Assessments:

Measurement (inches)	Acceptance Criteria	Reported Device Performance
Length	< .0050 Std Dev	Compliant
Width - Rail	< .0050 Std Dev	Compliant
Width - Paddle End	< .0050 Std Dev	Compliant
Width - Head End	< .0050 Std Dev	Compliant
Height - Rail	< .0050 Std Dev	Compliant
Height - Paddle End	< .0050 Std Dev	Compliant
Height – Head End	< .0050 Std Dev	Compliant
Hole Length	< .0050 Std Dev	Compliant
Hole Width	< .0050 Std Dev	Compliant
Hole to Proximal End	< .0050 Std Dev	Compliant
Hole to Distal End	< .0050 Std Dev	Compliant

Performance Data - Bench:

Assessment	Test Description	Acceptance Criteria	Reported Device Performance
RWE Data	Real-World Evidence (RWE) data presented, comparing the ExCellerator spatula (primary & complementary/secondary device) to the standard spatula for collecting and transferring cervical samples into ThinPrep vial.	Comparably equivalent or improved adequacy and diagnostics.	Demonstrated comparably equivalent or improved adequacy and diagnostics when using the ExCellerator spatula as both primary and complementary (secondary) device to collect and transfer cervical samples into the ThinPrep vial when compared with the standard spatula.
Validation Data	Validation data presented for safety and effectiveness when used as a collecting device and as an aid in transferring sample from IVD labeled cytobrush into ThinPrep PreservCyt Vial.	Safety and effectiveness demonstrated (implied for substantial equivalence).	Demonstrated safety and effectiveness of the ExCellerator device when used as collecting device and as an aid in transferring sample from the IVD labeled cytobrush into ThinPrep PreservCyt Vial.

Study Details:

The provided text focuses on demonstrating substantial equivalence to a predicate device (Pap Perfect Plastic Spatula, K861389) through various bench tests and real-world evidence, rather than a clinical study involving human readers or a standalone AI algorithm. Therefore, many of the requested details related to human reader studies are not applicable.

Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The sample sizes for these tests are not specified but are typically standard for ISO-compliant tests on material samples in a lab setting. The provenance is not explicitly mentioned but implied to be laboratory testing of the device material.
- Structural Assessments: Two production lots were used (Group A - 2017, Group B - 2009). The sample size within these groups (number of devices tested) is not specified. Provenance is from manufacturing lots.
- Dimensional Assessments: The sample size is not specified but measurement data was collected. Provenance is from manufacturing.
- Performance Data - Bench (RWE & Validation Data): The specific sample sizes for "RWE Data" and "Validation Data" are not provided. The document only states that "RWE data was presented" and "Validation data was presented." The provenance for RWE would logically be retrospective real-world clinical use data, but details (country, retrospective/prospective) are not given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the types of tests described (biocompatibility, structural, dimensional, and bench performance for a collection device). No pathology or diagnostic ground truth establishment by experts is mentioned. The RWE data refers to "adequacy and diagnostics" but doesn't detail how this was assessed or by whom to establish a ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no expert adjudication for diagnostic ground truth is described.
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:
- No MRMC study was conducted or described, as this is a physical cervical collection device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, structural, and dimensional tests, the ground truth is based on predefined engineering and ISO standards.
- For the "Performance Data - Bench" (RWE and Validation), the "adequacy and diagnostics" results from the RWE data would imply clinical outcomes or pathology reports served as a form of ground truth for sample quality, but the specifics are not detailed.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set. If "training set" refers to samples used for initial development or optimization, those details are not provided.
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

April 25, 2019

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

ExCell Company LLC Jim Snyder President 1540 West Main Street Carmel, IN 46032

Re: K182049

Trade/Device Name: ExCellerator Cervical Collection Device Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: Class II Product Code: HHT Dated: July 27, 2018 Received: July 31, 2018

Dear Mr. Snyder:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yun-fu Hu -S

for Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182049

Device Name ExCellerator Cervical Collection Device

Indications for Use (Describe)

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

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR [807.92(a)(1)]

Date Prepared:	April 23, 2019
510(k) Owner:	ExCell Company LLC1540 W. Main StreetCarmel, IN 46032317.358.9610 psnyper7x7@gmail.com
Contact:	Jim Snyder – President
Trade Name:	ExCellerator™
Common Name:	Cervical Collection Device (spatula)
Classification Name:	Collector, Cervical Cytological (Obstetric-gynecologic specialized manual instrument)
Device Classification:	Class II
Product Code:	HHT
Predicate Device:	Pap Perfect Plastic Spatula (K861389)

Device Description:

Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.

Use Description:

The ectocervix is sampled using the ExCellerator cervical cytological spatula. The ● endocervix is sampled using the IVD labeled endocervical brush.
The clinician uses both devices as she/he would ordinarily in the manual application of . the devices to the ectocervix and endocervix.
Cells are transferred from the spatula and endocervical brush into liquid preservative ● (ThinPrep PreservCyt) in accordance with standard protocol.
Removal of the sample from the endocervical brush is aided by the ExCellerator by . utilizing the hole in the device to tease the sample off the brush according to the package insert.

Intended Use:

The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush), to the PreservCyt solution for the ThinPrep Pap testing.

The ExCellerator device must be used with an IVD labeled endocervical brush.

{4}------------------------------------------------

Indications for Use See Intended Use above.

Technological Characteristics:

The ExCellerator™ cervical cytological spatula is a standard device in terms of overall design and use, and satisfies the definition of a cytological cervical spatula, which is: "A cytological cervical spatula is a blunt instrument used to scrape and remove cytological materials from the surface of the cervix or vagina." – 21 CFR 884.4530 (a)(13).

The ExCellerator™ cervical cytological spatula is different in one (1) respect. It has an oblong opening "Hole" ~0.250 x 0.130-in. in size, located ~6.19-in. on center from the spatula paddle end, and slightly less than 1' from the head end, which places it between the raised support ribs of the shaft. Its location facilitates the user's placing the tip of the brush into the opening while the dog bone end is immersed in liquid preservative. The hole does not impact the way the spatula is used to sample the ectocervix.

New technological characteristic 0

The hole in the exCellerator™ can be considered a new technological characteristic. Its use minimizes inter-operator variability among collectors in removing the cytological sample from the endocervical brush. It does not affect how either the spatula or endocervical brush are used to remove cells from the ectocervix and endocervix, how cells are transferred from either device into liquid preservative, or how and what testing is performed on the sample.

Testing - Biocompatibility:

Biocompatibility tests were conducted to ensure safety and effectiveness of the device:

Assessment	Test	Criteria	Result
Cytotoxicity	MEM Elution Cytotoxicity Assay(ISO)	Non-Cytotoxic	Passed
Irritation	Vaginal Mucosal Irritation Test(ISO)	Non-Irritant	Passed
Sensitivity	Guinea Pig Maximization Test(ISO)	Non-sensitizer	Passed

Summary Table: Biocompatibility Assessments

Testing - Performance - Non-Clinical:

Mechanical tests were conducted to demonstrate substantial equivalence of the device to the predicate in terms of safety and effectiveness.

{5}------------------------------------------------

Summary Table: Structural Assessments

Assessment	Test Performed	AcceptanceCriteria	Control Mode	Group	Result
Static Bend	Static CantileverBend	< 2-3mm	Displacement(Bend)	A	Passed
Static Bend	Static CantileverBend	< 2-3mm	Displacement(Bend)	B	Passed
Static Tension	Static Tension	< 1mm	Deformation	A	Passed
Static Tension	Static Tension	< 1mm	Deformation	B	Passed
Static Torsion	Static Torsion	< 45°	AngularDisplacement	A	Passed
Static Torsion	Static Torsion	< 45°	AngularDisplacement	B	Passed

*Production Lots: Group A - 2017, Group B - 2009 Shelf Life Successfully Assessed to be > 7 years

Testing - Dimensional Measures

Dimensional Assessments were made to ensure production consistency of the device.

Summary Table: Dimensional Assessments
----------------------------------------	--

Measurement (inches)	Acceptance Criteria	Result
Length	< .0050 Std Dev	Compliant
Width - Rail	< .0050 Std Dev	Compliant
Width - Paddle End	< .0050 Std Dev	Compliant
Width - Head End	< .0050 Std Dev	Compliant
Height - Rail	< .0050 Std Dev	Compliant
Height - Paddle End	< .0050 Std Dev	Compliant
Height – Head End	< .0050 Std Dev	Compliant
Hole Length	< .0050 Std Dev	Compliant
Hole Width	< .0050 Std Dev	Compliant
Hole to Proximal End	< .0050 Std Dev	Compliant
Hole to Distal End	< .0050 Std Dev	Compliant

Performance Data - Bench:

Bench testing and data analysis were performed to demonstrate substantial equivalence of the ExCellerator spatula to the predicate in terms of safety and effectiveness.

RWE Data: RWE data was presented and demonstrated comparably equivalent or . improved adequacy and diagnostics when using the ExCellerator spatula as both primary and complementary (secondary) device to collect and transfer cervical samples into the ThinPrep vial when compared with the standard spatula.

{6}------------------------------------------------

Validation Data: Validation data was presented to demonstrate safety and effectiveness of . the ExCellerator device when used as collecting device and as an aid in transferring sample from the IVD labeled cytobrush into ThinPrep PreservCyt Vial.

Substantial Equivalence Discussion

The ExCellerator™ cervical cytological spatula is processed by manufacturing methods and materials that are similar to those used for manufacturing of the predicate device: Medscand® Pap-Perfect Plastic Spatula. The Medscand® Pap-Perfect Plastic Spatula is the approved and distributed device within the ThinPrep Pap Test System.

ExCellerator Testing and Validation Conclusion: The ExCellerator cervical spatula has met or exceeded validation criteria for all the tests performed and is considered substantially equivalent to the predicate device.

New device:	ExCellerator™ cervical cytological spatula
Predicate device:	Spatula, cervical, cytological
Trade name:	Pap Perfect Plastic Spatula
Model number:	Cooper Surgical Item #11080
510(k) submitter/holder:	International Cytobrush, Inc.
510(k) number:	K861389

Intended Use: Primary Use: Same as the predicate device: For collecting ectocervical cytological material. Secondary Use: As aid in achieving a more complete transfer of cytological material from the endocervical brush (cytobrush) into the PreservCyt Vial for Pap smear testing.

Item	Candidate Device	Predicate
Device Name	ExCellerator Cervical Spatula	Pap Perfect Spatula
510(k) Number	K182049	K861389
Product Code	HHT	Same
Intended Use	The ExCellerator™ Cervical Collection Deviceis a cervical spatula intended for collectingectocervical specimens for the ThinPrep Pap test.The device is also intended to be used to aid in amore complete transfer of the specimen materialfrom the endocervical brush (cytobrush), to thePreservCyt solution for ThinPrep Pap testing.The ExCellerator™ device must be used with anIVD labeled endocervical brush.The collected specimen is transferred from theexCellerator™ device and endocervical brush	SameSecondary Feature NotApplicable

Comparison with Predicate Device

{7}------------------------------------------------

	into ThinPrep vial in accordance with thespecified procedure.'Caution: For use by medical professionals only'
Material	Plastic	Same
KeyDimensions	Overall ~7.13"Length:	Same
	Paddle ~.50"EndWidth:	Same
	Head ~.70"EndWidth:	Same
Supplied	Non-Sterile - Disposable	Same

o New technological characteristics

The hole in the exCellerator™ can be considered a new technological characteristic. Its use minimizes inter-operator variability among collectors when removing the cytological sample from the endocervical brush. It does not affect how either the spatula or endocervical brush are used to remove cells from the ectocervix and endocervix, how cells are transferred from either device into the liquid preservative, or how and what testing is performed on the sample.

Substantial Equivalence Decision

The subject and predicate devices have similar intended use and technological characteristics. Dimensions and material are the same. Biocompatibility testing, Mechanical testing and Performance data- Bench (Rear World Evidence data and Validation data), all met the pre-specified study acceptance criteria and demonstrated safety and effectiveness of the ExCellerator Cervical Collection Device. The subject device is substantially equivalent to the predicate device.

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.