(332 days)
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.
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.
The URAMIX CuraWay Automatic Core Biopsy Instrument is a medical device intended for obtaining biopsies from soft tissues. The provided text outlines a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., effect size of human readers, standalone performance, training set details) are not applicable or cannot be extracted from the given document as it primarily covers non-clinical engineering and design comparisons.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of diagnostic performance metrics (like sensitivity, specificity, or AUC). Instead, it provides a comparison of engineering and functional characteristics to a predicate device, aiming to show substantial equivalence. The "performance" reported is primarily in relation to these comparative metrics.
| Feature/Test | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device) | Outcome |
|---|---|---|---|
| Intended Use | Obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors). Not for bone. | Intended for use in obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors). Not for bone or breast. | Similar clinical condition, same intended purpose and site. (Note: Subject device adds "not for breast") |
| Material | Stainless steel + ABS | Shaft: Medical grade stainless steel (SUS304/06Cr19Ni10). Handle/Actuator: Acrylonitrile Butadiene Styrene (ABS). | Same material used. |
| Types/Sizes (Gauges) | 14G, 16G, 18G, 20G | 12G, 14G, 16G, 18G, 20G | 12G also available, no significant influence on clinical use. |
| Length (mm) | 100mm, 160mm, 200mm, 250mm | 80mm, 100mm, 130mm, 1600mm, 200mm, 250mm | Different lengths available, no significant influence on clinical use. |
| Slot size | 18mm | 18mm | Same. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | ISO 10993-1, ISO 10993-5, ISO 10993-10 | Same standards met. |
| Sterilization Method | EO sterilization | EO sterilization | Same. |
| Puncture Force Value | Predicate: 5.3N | Subject: 2.7N | Subject device has lower puncture force. |
| Resistance during operation | Predicate: none | Subject: none | Same. |
| Abnormal noise during operation | Predicate: none | Subject: none | Same. |
| Connection firmness (needle tube + plastic parts) | Predicate: 181 to 230N | Subject: 190 to 212N | Within comparable range. |
| Ex-vivo tissue studies (sample length & weight) | Similar length, weight between predicate and subject. | Equivalent tissue samples in terms of length and weight (porcine muscle, liver). | Equivalent. |
| Cytotoxicity | Per ISO 10993-5 | In vitro cytotoxicity performed. | Demonstrated compliance. |
| Irritation and Skin Sensitization | Per ISO 10993-10 | Tests performed. | Demonstrated compliance. |
| Systemic Toxicity | Per ISO 10883-11 | Test performed. | Demonstrated compliance. |
| Sterility Test | Per ISO 11138-2, ISO 11737-2 | Sterility test performed. | Demonstrated compliance. |
| EO Residuals | Per EN ISO 10993-7 | 1.13 mg/device | Demonstrated compliance. |
| Packaging & Shelf-life | Per ISTA2A and ASTM F1980-16 for 3-year shelf life. | 3-year shelf life. | Demonstrated compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "ex-vivo tissue studies (porcine muscle, liver)" which suggests an experimental test set. However, it does not specify the sample size for these ex-vivo studies beyond stating "equivalent tissue samples." The data provenance is implied to be laboratory testing rather than human clinical data. No country of origin for this specific testing data is given, but the manufacturer is based in China. This is not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The comparisons and tests described are for physical and material characteristics of the device, not diagnostic performance requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not an imaging or diagnostic AI device requiring adjudication of human expert interpretations. The testing focuses on mechanical and material properties.
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
Not applicable. The URAMIX CuraWay Automatic Core Biopsy Instrument is a physical medical instrument (a biopsy needle), not an AI device or an imaging/diagnostic AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo tissue studies, the ground truth was implied by the objective measurements of sample length and weight taken from the porcine tissues. For other non-clinical tests (biocompatibility, sterility, etc.), the ground truth is compliance with recognized international standards (e.g., ISO, ASTM).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is relevant for this device.
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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
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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 (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
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Indications for Use
510(k) Number (if known) K203141
Device Name
Uramix Curaway Automatic Core Biopsy Instrument
Indications for Use (Describe)
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.
| 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
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.
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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.
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COMPARISON TO PREDICATE
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Item | BARD® MAX-CORE® DisposableCore Biopsy Instrument, K133948 | URAMIX CuraWay Automatic CoreBiopsy Instrument, K203141 | Outcome |
| IntendedUse | Obtaining biopsies from soft tissuessuch as liver, kidney, thyroid,prostate, spleen, lymph nodes andvarious soft tissue tumors.It is not intended for use in bone. | The URAMIX Curaway AutomaticCore Biopsy Instrument isintended for use in obtainingbiopsies from soft tissues suchas liver, kidney, prostate, spleen,lymph nodes and various softtissue tumors. It is not intendedfor use in bone, or breast. | It was used for the sameclinical condition, and sameintended purpose, and at thesame site. |
| Material | Stainless steel + ABS | The shaft of cutting cannula and innerstylet is made of medical grade stainlesssteel (SUS304/06Cr19Ni10). The operatinghandle and actuator button are made ofacrylonitrile butadiene styrene (ABS). | Same material used |
| Types/Sizes | 14G, 16G, 18G, 20G | 12G, 14G, 16G, 18G, 20G | 12G is also available fromZhejiang CuraWay, this hasno significant influence onclinical use. |
| DesignAttributes | Each needle has numerically orderedcentimeter markings on the outercannula to provide reference for depthplacementNeedles feature an adjustable needlestop which allows the user to restrictforward movement, localizing theneedle tip to the biopsy siteColor coded stylet hubs indicategauge size of needles available in avariety of gauge sizes and centimeterlengthsAvailable with an echogenic tip on theouter cannula to promote accurateplacement under ultrasound guidance | Automatic Core Biopsy Instrument is apuncture needle consisting of an innerstylet and a cutting cannula with etched tip(s. Figure 1). The cutting cannula hasnumerically ordered centimeter markingson it to provide reference for depthplacement. In the distal area of the cuttingcannula, an ultrasound enhancement isavailable to promote accurate placementunder ultrasound or X-ray guidance. Anadjustable depth stopper allows the user torestrict forward movement, localizing theneedle tip to the biopsy site. The Type A isa variant in position of the depth stopper.The operating handle is color-coded, whichindicates gauge size of the needle. Theneedle is protected in a needle sheath.Automatic Core Biopsy Instrument isavailable in several needle gauge sizesand lengths. | Very similar design |
| Length(mm) | 100mm, 160mm, 200mm, 250mm | 80mm, 100mm, 130mm, 1600mm, 200mm,250mm | This has no significantinfluence on clinical use. |
| Slot size | 18mm | 18mm | Same |
| Structurea. Photo(examples) | Very similar structure anddesign concept | ||
| Packaging | Tyvek 1073B + PE | Tyvek 1073B + PET/PE | Critical component Tyvek isthe same.Both packaging systems arecommon packaging. |
| Biocompatibility | ISO 10093-1, ISO 10993-5 and ISO10993-10 | ISO 10093-1, ISO 10993-5 and ISO 10993-10 | Same. |
| Sterilization method | EO sterilization | EO sterilization | Same. |
| Conclusion | After comparison of the device in question with the predicate device, K133948 regardingclinical, technical and biological characteristics, it can be concluded that both devices havesimilar design, perform the same function under the same clinical conditions. They use thesame materials and have the same durability. Tissue penetration and sample size are the sameand the device is in contact with the same human tissues and body fluids. They can beconsidered as equivalent devices. |
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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 ●
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- 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
§ 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.