K Number

Device Name

Uramix CuraWay Biopsy Needle

Manufacturer

Uramix, Inc.

Date Cleared

2021-09-17

(332 days)

Product Code

KNW MAN

Regulation Number

876.1075

Intended Use

The Uramix Curaway Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast.

Device Description

The URAMIX CuraWay Automatic Core Biopsy Instrument is a single use only core biopsy device and is individually packaged and sterilized. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified to maintain the sterilization condition of the device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes. The 18 gauge is the one used for current intended marketing, for prostate and kidney biopsies.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133948

Reference Devices

K133948

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical biopsy instrument and its performance characteristics, with no mention of AI or ML capabilities.

Therapeutic

No
The device is described as an instrument for obtaining biopsies, which is a diagnostic procedure, not a therapeutic one. Its purpose is to collect tissue samples for analysis.

Diagnostic

Yes

The device is used to obtain biopsies, which are then analyzed to diagnose diseases or conditions in soft tissues. This process of obtaining samples for diagnosis classifies it as a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly states it is a "single use only core biopsy device" and details physical characteristics like needle gauge sizes, lengths, and actuator buttons, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside of the body.
Device Function: The Uramix Curaway Automatic Core Biopsy Instrument is a tool used inside the body to obtain a tissue sample. It is a surgical instrument, not a diagnostic test performed on a sample.
Intended Use: The intended use clearly states it's for "obtaining biopsies from soft tissues." This is a sample collection function, not a diagnostic analysis function.

While the tissue sample obtained may be used for subsequent in vitro diagnostic testing (like pathology analysis), the biopsy instrument itself is not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

KNW

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

The following testing was conducted to demonstrate the safe and effective use of the URAMIX Curaway Automatic Core Biopsy Instrument:

Biocompatibility Testing per ISO 10993-5, including in vitro cytotoxicity ●
ISO 10993-10 tests for irritation and skin sensitization ●
ISO 10883-11 test for systemic toxicity ●
Sterilization Testing per ISO 11138-2, and ISO 11737-2 sterility test ●
Residuals per EN ISO 10993-7 EO residuals = 1.13 mg/device ●
Packaging and Shelf-life per ISTA2A and ASTM F1980-16 3-year shelf life ●
Puncture Force Value: Predicate 5.3N; Subject 2.7N ●
Resistance during operation: Predicate none; Subject none ●
Abnormal noise during operation: Predicate none: Subject none .
Connection firmness (needle tube + plastic parts): P 181 to 230N; S 190 to 212N ●
Samples of various tissues: similar length, weight between Predicate and Subject .
The ex-vivo tissue studies (porcine muscle, liver) demonstrate equivalent tissue . samples in terms of length and weight.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K133948

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".

September 17, 2021

Uramix, Inc. % Michael Mooreville, MD Medical Director Uramix, Inc 272 N. Lansdowne Ave. Lansdowne, Pennsylvania 19050

Re: K203141

Trade/Device Name: URAMIX CuraWay Automatic Core Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: July 21, 2021 Received: July 21, 2021

Dear Dr. Mooreville :

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 approv al 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 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 (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 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

Indications for Use

510(k) Number (if known) K203141

Device Name

Uramix Curaway Automatic Core Biopsy Instrument

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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SUBMITTER

Uramix, Inc 272 N. Lansdowne Ave. Lansdowne, PA 19050

Contact Person:	Michael Mooreville, MD
	Medical Director
Telephone:	(610) 304-9070
Email:	uramix@comcast.net

DEVICE

Name of the Device: URAMIX CuraWay Automatic Core Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Instrument, Biopsy/Regulatory Class II Regulatory Specialty: Gastroenterology/Urology KNW Product code:

Manufacturer: Zhejiang CuraWay Medical Technology Co., Ltd Company Address: Room 106, Building 1, No.600, 21st Street, Qiantang New Area, Hangzhou, Zhejiang, China

PREDICATE DEVICE

K133948, BARD® MAX-CORE® Disposable Core Biopsy Primary:

DEVICE DESCRIPTION

K203141

510(k) Summary

| ABN 1208,
ABN 1208A | ABN 1408,
ABN 1408A | ABN 1608,
ABN 1608A | ABN 1808,
ABN 1808A | ABN 2008,
ABN 2008A |
|------------------------|-------------------------|--------------------------|------------------------|--------------------------|
| ABN 1210,
ABN 1210A | ABN 1410,
ABN 1410A | ABN 1610,
ABN 1610A | ABN 1810,
ABN 1810A | ABN 2010,
ABN 2010A |
| ABN 1213,
ABN 1213A | ABN 1413,
ABN 1413A | ABN 1613,
ABN 1613A | ABN 1813,
ABN 1813A | ABN 2013,
ABN 2013A |
| ABN 1216,
ABN 1216A | ABN 1416,
ABN 1416A | BN 1616,
ABN 1616A | ABN 1816,
ABN 1816A | ABN 2016,
ABN 2016A |
| ABN 1220,
ABN 1220A | ABN 1420,
ABN 1420A | ABN 1620,
ABN 1620A | ABN 1820,
ABN 1820A | ABN 2020,
ABN 2020A |
| ABN 1225,
ABN 1225A | ABN 1425,
ABN 1425A | ABN 1625,
ABN 1625A | ABN 1825,
ABN 1825A | ABN 2025,
ABN 2025A |
| 12G
(2.7mm)
Blue | 14G
(2.1mm)
Green | 16G
(1.7mm)
Violet | 18G
(1.2mm)
Pink | 20G
(0.9mm)
Yellow |

According to gauge and length, the following variants are available:

The operating handle is color coded and the Type A is a variant in the position of the needle markings, which provide reference for depth of placement.

INDUCATIONS FOR USE

The URAMIX CuraWay Automatic Core Biopsy Instrument is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue tumors. It is not intended for use in bone, or breast.

COMPARISON TO PREDICATE

	Predicate Device	Subject Device
Item	BARD® MAX-CORE® Disposable
Core Biopsy Instrument, K133948	URAMIX CuraWay Automatic Core
Biopsy Instrument, K203141	Outcome
Intended
Use	Obtaining biopsies from soft tissues
such as liver, kidney, thyroid,
prostate, spleen, lymph nodes and
various soft tissue tumors.
It is not intended for use in bone.	The URAMIX Curaway Automatic
Core Biopsy Instrument is
intended for use in obtaining
biopsies from soft tissues such
as liver, kidney, prostate, spleen,
lymph nodes and various soft
tissue tumors. It is not intended
for use in bone, or breast.	It was used for the same
clinical condition, and same
intended purpose, and at the
same site.
Material	Stainless steel + ABS	The shaft of cutting cannula and inner
stylet is made of medical grade stainless
steel (SUS304/06Cr19Ni10). The operating
handle and actuator button are made of
acrylonitrile butadiene styrene (ABS).	Same material used
Types/
Sizes	14G, 16G, 18G, 20G	12G, 14G, 16G, 18G, 20G	12G is also available from
Zhejiang CuraWay, this has
no significant influence on
clinical use.
Design
Attributes	Each needle has numerically ordered
centimeter markings on the outer
cannula to provide reference for depth
placement
Needles feature an adjustable needle
stop which allows the user to restrict
forward movement, localizing the
needle tip to the biopsy site
Color coded stylet hubs indicate
gauge size of needles available in a
variety of gauge sizes and centimeter
lengths
Available with an echogenic tip on the
outer cannula to promote accurate
placement under ultrasound guidance	Automatic Core Biopsy Instrument is a
puncture needle consisting of an inner
stylet and a cutting cannula with etched tip
(s. Figure 1). The cutting cannula has
numerically ordered centimeter markings
on it to provide reference for depth
placement. In the distal area of the cutting
cannula, an ultrasound enhancement is
available to promote accurate placement
under ultrasound or X-ray guidance. An
adjustable depth stopper allows the user to
restrict forward movement, localizing the
needle tip to the biopsy site. The Type A is
a variant in position of the depth stopper.
The operating handle is color-coded, which
indicates gauge size of the needle. The
needle is protected in a needle sheath.
Automatic Core Biopsy Instrument is
available in several needle gauge sizes
and lengths.	Very similar design
Length
(mm)	100mm, 160mm, 200mm, 250mm	80mm, 100mm, 130mm, 1600mm, 200mm,
250mm	This has no significant
influence on clinical use.
Slot size	18mm	18mm	Same
Structure
a. Photo
(examples)			Very similar structure and
design concept
Packaging	Tyvek 1073B + PE	Tyvek 1073B + PET/PE	Critical component Tyvek is
the same.
Both packaging systems are
common packaging.
Biocompati
bility	ISO 10093-1, ISO 10993-5 and ISO
10993-10	ISO 10093-1, ISO 10993-5 and ISO 10993-
10	Same.
Sterilizatio
n method	EO sterilization	EO sterilization	Same.
Conclusion	After comparison of the device in question with the predicate device, K133948 regarding
clinical, technical and biological characteristics, it can be concluded that both devices have
similar design, perform the same function under the same clinical conditions. They use the
same materials and have the same durability. Tissue penetration and sample size are the same
and the device is in contact with the same human tissues and body fluids. They can be
considered as equivalent devices.

SUMMARY OF NON CLINICAL TESTING

The following testing was conducted to demonstrate the safe and effective use of the URAMIX Curaway Automatic Core Biopsy Instrument:

Biocompatibility Testing per ISO 10993-5, including in vitro cytotoxicity ●
ISO 10993-10 tests for irritation and skin sensitization ●
ISO 10883-11 test for systemic toxicity ●
Sterilization Testing per ISO 11138-2, and ISO 11737-2 sterility test ●
Residuals per EN ISO 10993-7 EO residuals = 1.13 mg/device ●
Packaging and Shelf-life per ISTA2A and ASTM F1980-16 3-year shelf life ●

Puncture Force Value: Predicate 5.3N; Subject 2.7N ●
Resistance during operation: Predicate none; Subject none ●
Abnormal noise during operation: Predicate none: Subject none .
Connection firmness (needle tube + plastic parts): P 181 to 230N; S 190 to 212N ●
Samples of various tissues: similar length, weight between Predicate and Subject .
The ex-vivo tissue studies (porcine muscle, liver) demonstrate equivalent tissue . samples in terms of length and weight.

CONCLUSION

Based upon the performance data provided in this submission and comparing indicated use, design, materials, principle of operation and overall technological characterisitics, the URAMIX Curaway Automatic Core Biopsy Instrument has been determined to be substantially equivalent to the predicate device, BARD Max-Core, K133948