(171 days)
Not Found
No
The device description details a manual, mechanical biopsy needle with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML. The performance studies are bench tests and ex vivo comparisons, not studies evaluating algorithmic performance.
No.
A therapeutic device is used for treating or curing a disease or condition; this device is used for diagnostic purposes (obtaining tissue samples).
No
The device is a biopsy needle used to obtain tissue samples (bone marrow core biopsies and aspirates). It is not described as analyzing or interpreting those samples for diagnostic purposes. It is a tool for sample collection, which is a precursor to diagnosis.
No
The device description clearly outlines a physical, manual biopsy needle with components like a stylet, cannula, and depth guard, intended for physical insertion and sample collection. There is no mention of software as part of the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. This is a procedure to collect a sample from the body.
- Device Description: The device is a manual, sterile and disposable biopsy needle designed for the physical act of obtaining a sample.
- Lack of Diagnostic Function: The description focuses on the mechanics of sample collection. There is no mention of the device being used to examine the sample or provide any diagnostic information about the sample itself. IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions.
This device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test, but the device itself does not perform the diagnostic test.
N/A
Intended Use / Indications for Use
The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration.
The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained.
The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and/or bone marrow
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)
Non-Clinical Testing:
- Packaging and shelf-life testing per ASTM F1980: 2016.
- Biocompatibility evaluation per ISO 10993-1: 2018, ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-11: 2017, and ISO 10993-23: 2021.
- Sterilization validation per ISO 11135: 2014, ISO 11138-1: 2017.
- EO Residuals testing per ISO 10993-7: 2008.
- Sterility testing per ISO 11737-2: 2019.
Bench tests (puncture test, torque test, stiffness test, toughness test and corrosion resistance test) were conducted on the subject Bone Marrow Biopsy Needle, all test results meet the performance requirements. Comparison test, including ex vivo sample quality comparison on the subject device and predicate device was conducted and all the result shows the subject are substantially equivalent to the predicate devices.
Clinical data:
No clinical data was provided.
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 24, 2025
Zhejiang CuraWay Medical Technology Co., Ltd. Caili Cao RA Specialist Room 106, Building 1, No. 600 21st Avenue, Baiyang Sub-district, Oiantang New District Hangzhou, Zhejiang 310018 China
Re: K242322
Trade/Device Name: Bone Marrow Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: December 27, 2024 Received: December 27, 2024
Dear Caili Cao:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Jessica Carr -S
Jessica Carr, PhD 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Bone Marrow Biopsy Needle (BNMAB-1, BNMA/CB-1)
Indications for Use (Describe)
The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K) Summary
| Company Name/Owner | Zhejiang CuraWay Medical Technology Co., Ltd. | |||
|---|---|---|---|---|
| Contact person/Author | Caili Cao | |||
| Date prepared | December 9, 2024 | |||
| Contact details Address | Room 106, Building 1, No. 600, 21st Avenue, Baiyang | |||
| Sub-district, Qiantang New District, 310018 Hangzhou | ||||
| City, Zhejiang Province, China | ||||
| Contact phone number | 86-571-87016876 | |||
| Bone | Marrow | Biopsy | Needle | |
| Trade name Common | Bone Marrow Biopsy Needle | |||
| name Classification | Gastroenterology-urology biopsy instrument | |||
| name Review panel | Gastroenterology/Urology | |||
| Regulation number | 21 CFR 876.1075 | |||
| Product code | KNW | |||
| Predicate device | Jamshidi Evolve Bone Marrow Biopsy/Aspiration | |||
| Needle (K171531) |
5
1. Device Description
This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration.
The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained.
The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.
2. Indications for use
The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.
3. Substantial equivalence comparison with predicate device
Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (K171531) is selected as a predicate device to the subject Bone Marrow Biopsy Needle.
The subject device and predicate device are based on the same technological elements and intended use. There are several design differences, but do not cause a risk to the safety and effectiveness of the product, instead, such differences make it easier for users to operate the device. Detailed information please refer to comparison table below.
6
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Comparison | |||
| Elements | Bone Marrow Biopsy | ||
| Needle | Jamshidi Evolve Bone | ||
| Marrow | |||
| Biopsy/Aspiration Needle | Comment | ||
| Classification | |||
| Regulation | 876.1075 | 876.1075 | Same |
| Product Code | KNW | KNW | Same |
| 510(k) Number | K242322 | K171531 | / |
| Indications for | |||
| use | The product is indicated | ||
| for use in aspirating bone | |||
| marrow and for use in | |||
| obtaining core biopsy | |||
| samples of bone and/or | |||
| bone marrow. | Indicated for use in | ||
| aspirating bone marrow and | |||
| for use in obtaining core | |||
| biopsy samples of bone | |||
| and/or bone marrow. | Same | ||
| Operation | |||
| mechanics | Manual | Manual | Same |
| Overall Product | |||
| Design | Sterile, single-use, | ||
| disposable | Sterile, single-use, | ||
| disposable | Same | ||
| Patient/Tissue | |||
| Contact | |||
| Materials | Stainless steel and plastic | Stainless steel and plastic | Same |
| Contact site | Bone and bone marrow | Bone and bone marrow | Same |
| Biocompatibility | ISO 10093-1, ISO | ||
| 10993-5, ISO 10993-10, | |||
| ISO 10993-11, and ISO | |||
| 10993-23 | ISO 10093-1, ISO 10993-4, | ||
| ISO 10993-5, ISO 10993-10 | |||
| and ISO 10993-11 | Difference 1 | ||
| Sizes | 9G, 11G, 13G, 14G, 15G, | ||
| 16G, 18G | 8G, 11G, 13G | Difference 2 | |
| Needle length | |||
| (mm) | 25, 40, 55, 70, 100, 150 | 50, 89, 100, 150, 200 | Difference 3 |
| Cannula | |||
| Configuration | 304 stainless steel hollow | ||
| cannula | 304 stainless steel hollow | ||
| cannula | Same | ||
| Stylet | |||
| Configuration | Solid stainless steel wire | ||
| with three-edge | Solid stainless steel wire | ||
| with two-edge | Difference 4 | ||
| Subject Device | Predicate Device | Comment | |
| Comparison | |||
| Elements | Bone Marrow Biopsy | ||
| Needle | Jamshidi Evolve Bone | ||
| Marrow | |||
| Biopsy/Aspiration Needle | |||
| Handle | |||
| Configuration | Plastic handle on cannula | Plastic handle on cannula | Same |
| Bone Marrow | |||
| Extraction | |||
| Accessories | Extraction probe, probe | ||
| guide, cap, some versions | |||
| are provided with a | |||
| extraction cannula. | Probe, probe guide, cap, | ||
| some versions are provided | |||
| with a specimen cradle. | Same | ||
| (The | |||
| components | |||
| are translated | |||
| into different | |||
| words.) | |||
| Sterilization | |||
| method | EO sterilization | EO sterilization | Same |
7
4. Analysis of differences
Difference 1: Difference of biocompatibility
According to Annex A of ISO10993-1:2018, the Bone Marrow Biopsy Needle is an externally communicating medical device, contact with bone or bone barrow with less than 24 hours. Based on ISO 10093-1, the cytotoxicity, sensitization, irritation, acute systemic toxicity and pyrogen test could be the evaluation endpoint.
Difference 2: Difference of needle size
The needle size of the subject device is from 9G to 18G, and the needle size of predicate device is 8G to13G, the sizes of subject device 9G-13G are within the predicate device's, it is safe. For the 14G - 18G needles, Curaway has conducted in-vitro test use the worse case 18G needle, test results showed that the sampling performance can meet its intended purpose. The needle size difference does not cause new risks to device safety and effectiveness.
Difference 3: Difference of needle length
The length range of the subject product is 25 mm to 150 mm, while the predicate device's length range is 50 mm to 200 mm. Under the condition the diameter of the needle is certain, the long needles can penetrate deeper than short needles and cause more damage to the patient, therefore the short needles are safer than the long needles. Therefore, the needle length of 25mm and 40mm are not raise more safety risks than the length of 50mm.
8
Difference 4: Difference of stylet configuration
The stylet tip of subject device is a three-edge structure, the predicate device is a two-edge stylet. The material is same but design is different. Three-edge needle is a common type of needle, it has a special needle body structure like an arrow head with three sharp edges. Three-edge needles are widespread use in medicine, it has a sharp tip can improve the cutting efficiency. This design difference does not raise any new or significant questions of safety or effectiveness.
5. Non-Clinical Testing
The following testing was conducted to demonstrate the safe and effective use of subject devices and the standards that subject devices complied with:
- Packaging and shelf-life testing per ASTM F1980: 2016.
- Biocompatibility evaluation per ISO 10993-1: 2018, ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-11: 2017, and ISO 10993-23: 2021.
- Sterilization validation per ISO 11135: 2014, ISO 11138-1: 2017.
- EO Residuals testing per ISO 10993-7: 2008. ●
- Sterility testing per ISO 11737-2: 2019.
Bench tests (puncture test, torque test, stiffness test, toughness test and corrosion resistance test) were conducted on the subject Bone Marrow Biopsy Needle, all test results meet the performance requirements. Comparison test, including ex vivo sample quality comparison on the subject device and predicate device was conducted and all the result shows the subject are substantially equivalent to the predicate devices.
6. Clinical data
No clinical data was provided.
7. Conclusion
The indications for use, design and nonclinical performance testing indicate that the technological characteristics of subject device are equivalent to that of predicate devices. In conclusion, it can be determined that subject device is substantially equivalent to predicate devices.