(56 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functions for biopsy, with no mention of AI/ML algorithms, data processing, or learning capabilities.
No.
The device is used to facilitate the collection of diagnostic samples for analysis, not to treat a disease or condition.
No
Explanation: The device is used to perform a biopsy, which is a procedure to collect samples for diagnostic purposes. However, the device itself does not perform any diagnostic function; it is a tool for sample collection.
No
The device description explicitly mentions hardware components like a "scissor-slide mechanism" and an "internal motor," and the performance studies include testing related to hardware (accelerated aging, drop testing, electrical safety, and EMC).
Based on the provided information, the CytoCore device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The CytoCore is a device used to collect the specimen (cellular material) from the body. It is a tool for the biopsy procedure itself.
- The intended use is to perform a biopsy and harvest cellular material. The device's function is to facilitate the physical act of obtaining the sample.
- There is no mention of the device being used to analyze the collected sample. The description focuses on the mechanism for drawing back the plunger and oscillating the needle to collect the cells.
- The performance studies focus on the device's ability to collect material and its physical/electrical properties. They do not involve the analysis or interpretation of biological samples.
The CytoCore is a surgical/biopsy device used to obtain a sample that would then likely be sent to a laboratory for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Any patient population requiring the harvest of cellular material
Intended User / Care Setting
Hospitals, sub-acute, clinics and physician office settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accelerated ageing including environmental
- 1-year shelf-life
- Pre- and post-aging of the subject device
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.
Biocompatibility of materials
- The subject device has no patient contact.
- The user supplies the needle
Performance Testing
- Needle compatibility
- Comparative cellular harvest ability of the 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. The results demonstrate that the subject device was able to harvest or collect an equivalent to more cellular materials than the predicate.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known)
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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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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:
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
K972496 - TAO Aspirator and
Plastic Finger | Subject Device
Praxis Medical CytoCore
K200278 | Comparison | Does the difference raise
new questions of safety
and effectiveness? |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K972496 | TBD | N/A | N/A |
| Classification | KNW – Gastroenterology-Urology Biopsy
Instrument
21 CFR 876.1075 | KNW - Gastroenterology-Urology
Biopsy Instrument
21 CFR 876.1075 | Same | No |
| Indications for
Use | The TAO Aspirator™ is a device to hold a
10cc syringe for performing fine needle
aspiration of a palpable mass with one
hand, while stabilizing the mass to be
aspirated with the other hand. It is
equipped with a release button for
automatically drawing back the syringe
plunger, and is designed to be held in a
pencil-grip manner. This device places the
hand relatively close to the needle tip while
the hand is in a position of natural function.
enabling the needle movement using fine
motor control of the hand. | The Praxis Medical CytoCore is a
device to hold a syringe for performing
fine needle aspiration of an identified
mass with one hand. | Similar | No.
We have removed the
language from the predicate
device detailing how the
device is used. This was
discussed during Q191469
and FDA agreed that this
language was outdated. |
| Principle of
Operation | A needle is connected to a syringe and
inserted into a lesion. The syringe plunger
is retracted to create suction while the
operator moves the needle in an in-and-out
motion within the lesion at a rate of 5-10
times per second. The needle does not
rotate. | A needle is connected to a syringe and
inserted into a lesion. The syringe
plunger is retracted to create suction
while the subject device contains a
battery-powered internal motor that
rotates at 300 rpm the needle in an
alternating clockwise / counterclockwise
rotation. This altering rotation harvests
the cellular material in a similar way as
the in/out motion. | The subject device, can
be used with the in-and-
out motion similar to the
predicate. It differs in
that a battery powers a
motor that rotates the
needle. | Similar
Like the predicate the
technique can also be the
in/out motions, but the
alternating rotation of the
needles has shown to provide
equivalent cellular
harvesting.
The technology of needle
rotation does not raise new
concerns of safety that could
not be demonstrated as safe
and equivalent to the
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
Population | Any patient population requiring the
harvest of cellular material | Any patient population requiring the
harvest of cellular material | Similar | No |
| Environments of
use | Hospitals, sub-acute, pre-hospital | Hospitals, sub-acute, pre-hospital | Similar | No |
| Compatibility
with
environment and
other devices | Unknown | Typically, a CT or ultrasound
("imaging") is used to locate the
tissue/mass, however, there is no
interaction between a CT/Ultrasound
and the subject device | Similar | No |
| Prescriptive | Yes | Yes | Similar | No |
| Single patient
use, disposable | Yes | Yes | Similar | No |
| Basic
components | It is unclear if the predicate supplied a
needle, however, the device is a handle to
hold a 10cc syringe for the purpose of fine
needle aspiration | The end user supplies the needle as
directed within this submission (22-25
gauge), and a powered handle - the
subject device. All items are single use,
disposable | Similar | No |
| Needle Gauge | Unknown | 22-25 gauge | Similar | Performance testing included
a 22-25-gauge needle with
both the subject and
predicate devices |
| Materials | Unknown | Medical-grade plastic | Similar | No |
| Patient Contact | Unknown if the needle was included as
part of the system, but the device has no
patient contact | The CytoCore has no patient contact.
The user supplied needle contacts the
patient. | Similar | The user supplied needles
were previously cleared by
FDA and information can be
found in Section 18 with
510(k) numbers. |
| Power Source | Non-powered, user moves the needle in an
in-and-out motion to harvest cellular
material | DC-powered; internal built-in battery | Different | Use of a battery operated
motor to rotate the needle
does not raise different risks
that cannot be addressed via
testing. |
5
K200278
6
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 /
7
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.