The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor oscillates the needle to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.

AI/ML Overview

The Praxis Medical CytoCore is a biopsy instrument intended to hold a syringe for performing a biopsy of an identified mass with one hand. Below is a summary of its acceptance criteria and the study conducted to demonstrate that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Shelf-life & Durability	1-year shelf-life (accelerated aging). Pre and post-aging performance maintained.	Samples subjected to accelerated aging equivalent to 12 months. Performance maintained.
Drop Testing	Withstand 6 drops from 1m height onto a hard surface without damage affecting function.	Samples removed from shipping box, dropped twice from each of three orientations (total 6 drops) from 1m onto a 50mm ± 5mm thick hardwood board (hardwood > 600 kg/m3) on a concrete/rigid base. All samples passed.
Biocompatibility	No patient contact; therefore, ISO 10993 testing not required.	The subject device has no patient contact. (The user supplies the needle, which contacts the patient).
Cellular Harvest Ability (Equivalence)	Ability to harvest or collect cellular materials equivalent to or better than the predicate device.	Comparative cellular harvesting study showed the subject device (CytoCore) averaged 2.59, compared to the predicate's 1.85. The discussion states, "The results demonstrate that the subject device was able to harvest or collect an equivalent to more cellular materials than the predicate. We are making no claim of better performance only equivalence."
Electrical Safety & EMC	Compliance with applicable electrical safety and EMC standards.	The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-2-22 Edition 3.1 2012-10 standards for safety and IEC 60601-1-2: 2014 for EMC.
Needle Compatibility	Compatible with 22-25 gauge needles.	Performance testing included a 22-25-gauge needle with both the subject and predicate devices. (Implied successful compatibility during testing.)

2. Sample size used for the test set and the data provenance:

Cellular Harvest Ability (Comparative Performance Testing): Fifteen licensed physicians utilized the subject device and the predicate. The number of samples (e.g., biopsy procedures, tissue samples) each physician performed is not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given the nature of a comparative performance study with physicians actively using the device, it is most likely a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the cellular harvest ability study, fifteen licensed physicians were used.
Their specific qualifications beyond "licensed physicians" (e.g., years of experience, specialization) are not detailed in the provided document.

4. Adjudication method for the test set:

The document states that comparative cellular harvesting was "evaluated and scored." The specific adjudication method (e.g., 2+1, 3+1, independent review) for scoring the cellular harvest quantity/quality is not described.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described is a comparative cellular harvest ability study between two devices (Praxis Medical CytoCore vs. TAO Aspirator and Plastic Finger), not an AI-assisted diagnostic study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the Praxis Medical CytoCore is a physical medical device (a syringe-holding device with an internal motor for needle oscillation), not an algorithm or AI system.

7. The type of ground truth used:

For the comparative cellular harvest ability study, the ground truth appears to be established through the "evaluation and scoring" of the harvested cellular material, likely by the licensed physicians themselves or by an independent pathologist/cytologist assessing the quality and quantity of the biopsy samples. The exact nature of this "scoring" is not detailed, but it relates to the biological outcome of the biopsy procedure (i.e., how much and how well cellular material was collected).

8. The sample size for the training set:

This question is not applicable as the Praxis Medical CytoCore is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as #8.

Summary

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March 31, 2020

Praxis Medical, LLC % Paul Dryden ProMedic LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K200278

Trade/Device Name: Praxis Medical CytoCore Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 3, 2020 Received: February 4, 2020

Dear Paul Dryden:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200278

Device Name

Praxis Medical CytoCore

Indications for Use (Describe)

The CytoCore is a device to hold a syringe for performing a biopsy of an identified mass with one hand.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K200278

510(k) Summary

Date Prepared:	27-Mar-2020
----------------	-------------

I Submitter

	Praxis Medical LLC
	500 N Willow Ave #101
	Tampa, FL 33606
	T - (813) 545-8607

Submitter Contact:	John Fisher, M.D.
	CEO

Submission Correspondent:	Paul Dryden
	ProMedic, LLC

II Device

Proprietary or Trade Name:	Praxis Medical CytoCore
Common/Usual Name:	Instrument, Biopsy
Classification Name:	Instrument, Biopsy (21 CFR 876.1075)
Regulatory Class:	II
Product Code:	KNW

K972496 - TAO Aspirator and Plastic Finger III Predicate Device:

IV Device Description:

V Indications for Use:

The Praxis Medical CytoCore is a device to hold a syringe for performing a biopsy of an identified mass with one hand.

Environments of use: Hospitals, sub-acute, clinics and physician office settings.

VI Comparison of Technological Characteristics and Performance with the Predicate

Table 1 is a comparison - Subject Device vs. the Predicate, K972496 including technological characteristics and performance.

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K200278

Table 1: Comparison of the CytoCore vs. Tao Aspirator

Attribute	Predicate DeviceK972496 - TAO Aspirator andPlastic Finger	Subject DevicePraxis Medical CytoCoreK200278	Comparison	Does the difference raisenew questions of safetyand effectiveness?
K#	K972496	TBD	N/A	N/A
Classification	KNW – Gastroenterology-Urology BiopsyInstrument21 CFR 876.1075	KNW - Gastroenterology-UrologyBiopsy Instrument21 CFR 876.1075	Same	No
Indications forUse	The TAO Aspirator™ is a device to hold a10cc syringe for performing fine needleaspiration of a palpable mass with onehand, while stabilizing the mass to beaspirated with the other hand. It isequipped with a release button forautomatically drawing back the syringeplunger, and is designed to be held in apencil-grip manner. This device places thehand relatively close to the needle tip whilethe hand is in a position of natural function.enabling the needle movement using finemotor control of the hand.	The Praxis Medical CytoCore is adevice to hold a syringe for performingfine needle aspiration of an identifiedmass with one hand.	Similar	No.We have removed thelanguage from the predicatedevice detailing how thedevice is used. This wasdiscussed during Q191469and FDA agreed that thislanguage was outdated.
Principle ofOperation	A needle is connected to a syringe andinserted into a lesion. The syringe plungeris retracted to create suction while theoperator moves the needle in an in-and-outmotion within the lesion at a rate of 5-10times per second. The needle does notrotate.	A needle is connected to a syringe andinserted into a lesion. The syringeplunger is retracted to create suctionwhile the subject device contains abattery-powered internal motor thatrotates at 300 rpm the needle in analternating clockwise / counterclockwiserotation. This altering rotation harveststhe cellular material in a similar way asthe in/out motion.	The subject device, canbe used with the in-and-out motion similar to thepredicate. It differs inthat a battery powers amotor that rotates theneedle.	SimilarLike the predicate thetechnique can also be thein/out motions, but thealternating rotation of theneedles has shown to provideequivalent cellularharvesting.The technology of needlerotation does not raise newconcerns of safety that couldnot be demonstrated as safeand equivalent to thepredicate.
Attribute	Predicate Device	Subject Device	Comparison	Does the difference raise
	K972496 - TAO Aspirator and	Praxis Medical CytoCore		new questions of safety
	Plastic Finger	K200278		and effectiveness?
PatientPopulation	Any patient population requiring theharvest of cellular material	Any patient population requiring theharvest of cellular material	Similar	No
Environments ofuse	Hospitals, sub-acute, pre-hospital	Hospitals, sub-acute, pre-hospital	Similar	No
Compatibilitywithenvironment andother devices	Unknown	Typically, a CT or ultrasound("imaging") is used to locate thetissue/mass, however, there is nointeraction between a CT/Ultrasoundand the subject device	Similar	No
Prescriptive	Yes	Yes	Similar	No
Single patientuse, disposable	Yes	Yes	Similar	No
Basiccomponents	It is unclear if the predicate supplied aneedle, however, the device is a handle tohold a 10cc syringe for the purpose of fineneedle aspiration	The end user supplies the needle asdirected within this submission (22-25gauge), and a powered handle - thesubject device. All items are single use,disposable	Similar	No
Needle Gauge	Unknown	22-25 gauge	Similar	Performance testing includeda 22-25-gauge needle withboth the subject andpredicate devices
Materials	Unknown	Medical-grade plastic	Similar	No
Patient Contact	Unknown if the needle was included aspart of the system, but the device has nopatient contact	The CytoCore has no patient contact.The user supplied needle contacts thepatient.	Similar	The user supplied needleswere previously cleared byFDA and information can befound in Section 18 with510(k) numbers.
Power Source	Non-powered, user moves the needle in anin-and-out motion to harvest cellularmaterial	DC-powered; internal built-in battery	Different	Use of a battery operatedmotor to rotate the needledoes not raise different risksthat cannot be addressed viatesting.

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K200278

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VII Performance Data

The following performance data were provided in support of the substantial equivalence determination.

. Accelerated ageing including environmental
- 1-vear shelf-life O
- Pre- and post-aging of the subject device o
- Drop Testing O
. Biocompatibility of materials
- The subject device has no patient contact. o
- o The user supplies the needle
Performance Testing ●
- Needle compatibility o
- O Comparative cellular harvest ability of the subject vs. predicate device

Performance Testing - Pre and Post Aging

Finished, final samples were subjected to various conditioning scenarios. The samples were tested at the equivalent of 12 months of accelerated aging.

Drop Testing

The samples were removed from their shipping box and allowed to fall freely twice from each of three different starting orientations (for a total of 6 drops) from a height of 1m onto a 50 mm ± 5 mm thick hardwood board (hardwood > 600 kg/m3) lying flat on a concrete or a similar rigid base. Samples passed.

Comparative Performance Testing - Subject vs. Predicate Device

Fifteen licensed physicians utilized the subject device and the predicate. Comparative cellular harvesting was then evaluated and scored with of the subject device vs. the predicate averaging 1.85 (predicate) vs. 2.59 for CytoCore.

Discussion - The results demonstrate that the subject device was able to harvest or collect an equivalent to more celluar materials than the predicate. We are making no claim of better performance only equivalence.

Biocompatibility -

The subject device has no patient contact. Therefore ISO 10993 testing is not required. Discussion - The Praxis CytoCore has no patient contact, therefore, we did not perform biocompatibility.

Electrical Safety and EMC

Electrical safety and EMC testing were conducted on the subject device. The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-2-22 Edition 3.1 2012-10 standards for safety and IEC 60601-1-2: 2014 for EMC.

VIII Discussion of Differences and Conclusion

Discussion of Differences -

The primary difference between the Praxis CytoCore and – K972496 – TAO Aspirator and Plastic Finger is the use of a battery to run a DC motor in the subject device. The use of both the subject and predicate device is the similar in that they both collect tissue materials. The subject device uses a DC motor which rotates the user suppled needle in an alternating clockwise /

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counterclockwise rotation to assist in collecting tissue samples vs. that of the predicate which is an in/out motion. An evaluation of risk and testing for safety and effectiveness demonstrated that this difference was not significant. Performance testing shows that when compared to the predicate device, CytoCore was equivalent.

Substantial Equivalence Conclusion

The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric 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 § 876.9.