CytoCore

K200278 · Praxis Medical, LLC · KNW · Mar 31, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200278
• Device Name: CytoCore
• Applicant: Praxis Medical, LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Mar 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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

Device Story

The Praxis Medical CytoCore is a handheld, battery-powered syringe-holding device used in hospitals, clinics, and sub-acute settings to perform soft tissue biopsies. The operator inserts a user-supplied 22-25 gauge needle into a target mass. An internal DC motor oscillates the needle in an alternating clockwise/counterclockwise rotation at 300 rpm to facilitate cellular material harvesting. The device allows for one-handed operation, enabling the physician to maintain tactile sensation and fine motor control during needle placement. The device does not contact the patient; only the user-supplied needle contacts the patient. The output is a harvested tissue sample for diagnostic evaluation. The device is single-use and disposable.

Clinical Evidence

No clinical data. Bench testing included accelerated aging (1-year shelf-life), drop testing, and comparative cellular harvest performance. A study with 15 physicians compared the subject device to the predicate, showing the CytoCore achieved a mean cellular harvest score of 2.59 versus 1.85 for the predicate, demonstrating equivalence. Electrical safety and EMC testing confirmed compliance with AAMI ANSI ES 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Medical-grade plastic construction. DC-powered internal battery. Motorized needle rotation (300 rpm, alternating clockwise/counterclockwise). Dimensions/form factor: handheld syringe-holding device. Connectivity: None. Sterilization: Not specified. Standards: AAMI ANSI ES 60601-1:2005 + A1:2012, IEC 60601-2-22 Edition 3.1 2012-10, IEC 60601-1-2:2014.

Indications for Use

Indicated for any patient population requiring the harvest of cellular material via fine needle aspiration of an identified mass. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• TAO Aspirator and Plastic Finger (K972496)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 - [phone] |

| 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:

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.

#### 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 Device<br>K972496 - TAO Aspirator and<br>Plastic Finger | Subject Device<br>Praxis Medical CytoCore<br>K200278 | Comparison | Does the difference raise<br>new questions of safety<br>and effectiveness? |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K972496 | TBD | N/A | N/A |
| Classification | KNW – Gastroenterology-Urology Biopsy<br>Instrument<br>21 CFR 876.1075 | KNW - Gastroenterology-Urology<br>Biopsy Instrument<br>21 CFR 876.1075 | Same | No |
| Indications for<br>Use | The TAO Aspirator™ is a device to hold a<br>10cc syringe for performing fine needle<br>aspiration of a palpable mass with one<br>hand, while stabilizing the mass to be<br>aspirated with the other hand. It is<br>equipped with a release button for<br>automatically drawing back the syringe<br>plunger, and is designed to be held in a<br>pencil-grip manner. This device places the<br>hand relatively close to the needle tip while<br>the hand is in a position of natural function.<br>enabling the needle movement using fine<br>motor control of the hand. | The Praxis Medical CytoCore is a<br>device to hold a syringe for performing<br>fine needle aspiration of an identified<br>mass with one hand. | Similar | No.<br>We have removed the<br>language from the predicate<br>device detailing how the<br>device is used. This was<br>discussed during Q191469<br>and FDA agreed that this<br>language was outdated. |
| Principle of<br>Operation | A needle is connected to a syringe and<br>inserted into a lesion. The syringe plunger<br>is retracted to create suction while the<br>operator moves the needle in an in-and-out<br>motion within the lesion at a rate of 5-10<br>times per second. The needle does not<br>rotate. | A needle is connected to a syringe and<br>inserted into a lesion. The syringe<br>plunger is retracted to create suction<br>while the subject device contains a<br>battery-powered internal motor that<br>rotates at 300 rpm the needle in an<br>alternating clockwise / counterclockwise<br>rotation. This altering rotation harvests<br>the cellular material in a similar way as<br>the in/out motion. | The subject device, can<br>be used with the in-and-<br>out motion similar to the<br>predicate. It differs in<br>that a battery powers a<br>motor that rotates the<br>needle. | Similar<br>Like the predicate the<br>technique can also be the<br>in/out motions, but the<br>alternating rotation of the<br>needles has shown to provide<br>equivalent cellular<br>harvesting.<br>The technology of needle<br>rotation does not raise new<br>concerns of safety that could<br>not be demonstrated as safe<br>and equivalent to the<br>predicate. |
| 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? |
| Patient<br>Population | Any patient population requiring the<br>harvest of cellular material | Any patient population requiring the<br>harvest of cellular material | Similar | No |
| Environments of<br>use | Hospitals, sub-acute, pre-hospital | Hospitals, sub-acute, pre-hospital | Similar | No |
| Compatibility<br>with<br>environment and<br>other devices | Unknown | Typically, a CT or ultrasound<br>("imaging") is used to locate the<br>tissue/mass, however, there is no<br>interaction between a CT/Ultrasound<br>and the subject device | Similar | No |
| Prescriptive | Yes | Yes | Similar | No |
| Single patient<br>use, disposable | Yes | Yes | Similar | No |
| Basic<br>components | It is unclear if the predicate supplied a<br>needle, however, the device is a handle to<br>hold a 10cc syringe for the purpose of fine<br>needle aspiration | The end user supplies the needle as<br>directed within this submission (22-25<br>gauge), and a powered handle - the<br>subject device. All items are single use,<br>disposable | Similar | No |
| Needle Gauge | Unknown | 22-25 gauge | Similar | Performance testing included<br>a 22-25-gauge needle with<br>both the subject and<br>predicate devices |
| Materials | Unknown | Medical-grade plastic | Similar | No |
| Patient Contact | Unknown if the needle was included as<br>part of the system, but the device has no<br>patient contact | The CytoCore has no patient contact.<br>The user supplied needle contacts the<br>patient. | Similar | The user supplied needles<br>were previously cleared by<br>FDA and information can be<br>found in Section 18 with<br>510(k) numbers. |
| Power Source | Non-powered, user moves the needle in an<br>in-and-out motion to harvest cellular<br>material | DC-powered; internal built-in battery | Different | Use of a battery operated<br>motor to rotate the needle<br>does not raise different risks<br>that cannot be addressed via<br>testing. |

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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.