(151 days)
Not Found
No
The device description explicitly states it is "hand-operated, non-electronic" and the performance studies focus on mechanical and physical characteristics, not algorithmic performance. There is no mention of AI or ML in the document.
No
The device is used for taking biopsies, which are diagnostic procedures to collect tissue for examination, not for treating a disease or condition.
Yes
Explanation: The device is used to take cytological and histological biopsies of soft tissue, which are then used for pathological examination/testing. This process is a common method for diagnosing diseases.
No
The device description explicitly states it is a hand-operated, non-electronic device with physical components like a cannula, luer lock connector, and markings, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a biopsy needle used to obtain the tissue sample from the body. It is an instrument used in vivo (within the living body) to collect the specimen.
- Intended Use: The intended use is "for taking cytological and histological biopsies of soft tissue." This describes the process of collecting the sample, not analyzing it.
- Device Description: The description focuses on the physical characteristics and function of the needle for insertion and tissue collection.
- Performance Studies: The performance studies described are related to the physical properties and functionality of the needle itself (dimensions, strength, leakage, etc.), not the analysis of a biological sample.
The tissue sample collected by this device would then likely be sent to a laboratory for in vitro diagnostic testing (histological or cytological examination), but the needle itself is the tool for collection, not the diagnostic device.
N/A
Intended Use / Indications for Use
It is to be used for taking cytological and histological biopsies of soft tissue.
Product codes
KNW
Device Description
The device is a hand-operated, non-electronic, with Chiba tip for tissue pathological examination/testing.
- Trasparent Luer Lock connector.
- Sharpened cannula for a safe and painless insertion and penetration.
- External echogenic treatment for a correct positioning under ultrasound guidance.
- Centimeter markings and sliding stopper.
- Sterilized by ETO, shelf life 5 years.
It's a relatively invasive procedure and is performed by radiologist under guidance of imaging techniques such as ultrasound, X-ray.
This is a single-use device.
Not intended for use in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, X-ray
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist
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 bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Appearance;
- Cleanliness;
- Color code;
- Dimensions;
- Needle point;
- Patency of lumen;
- Tip structure;
- Bond between outer needle tube and hub;
- Bond between inner needle tube and hub;
- Sheath;
- Stiffness;
- Resistance to breakage;
- Resistance to corrosion;
- Scale identification;
- Positive pressure liquid leakage;
- Sub-atmospheric pressure air leakage;
- Stress cracking;
- Resistance to separation from axial load;
- Resistance to separation from unscrewing;
- Resistance to overriding;
The performance test results are indicated that performance of Fine Biopsy Needles meet the specific requirements. We concluded the proposed devices are substantially equivalent to the identified predicate devices in general appearance, dimension, needle tube performance, color, scale and connector.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
May 9, 2022
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K213683
Trade/Device Name: Promisemed Fine Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW
Dear Zearou Yang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 22, 2022. Specifically, FDA is updating this SE Letter with corrected Indications for Use as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, long.chen@fda.hhs.gov.
Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2022.05.09 14:58:54 -04'00'
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
1
Image /page/1/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.
April 22, 2022
Promisemed Hangzhou Meditech Co., Ltd. Mr. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K213683
Trade/Device Name: Promisemed Fine Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsv instrument Regulatory Class: Class II Product Code: KNW Dated: Februry 11, 2022 Received: February 24, 2022
Dear Mr. Yang:
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
2
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 medical devices and radiation-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,
Digitally signed by Long H. Chen Long H. Chen -S -s Date: 2022.04.22 14:15:46 -04'00'
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 Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K213683
Device Name Promisemed Fine Biopsy Needle
| Indications for Use (Describe) | It is to be used for taking cytological and histological biopsies of soft tissue. |
|---|---|
| -------------------------------- | ----------------------------------------------------------------------------------- |
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) |
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4
510(k) Summary
1. Date Prepared
April 25, 2022.
2. Submitter's Information
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China
Contact Name: Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
3. Trade Name, Common Name, Classification
Trade/Product Name: Promisemed Fine Biopsy Needle
Common Name: Fine Biopsy Needle
Classification name: Instrument, biopsy
Regulation Number: 876.1075
Device Class: Class II
Product Code: KNW
4. Identification of Predicate Device
K970872: Pan® Aspirating Needle (Chiba)
5. Description of the Device
The device is a hand-operated, non-electronic, with Chiba tip for tissue pathological examination/testing.
- -Trasparent Luer Lock connector.
- Sharpened cannula for a safe and painless insertion and penetration. -
5
- External echogenic treatment for a correct positioning under ultrasound guidance.
- -Centimeter markings and sliding stopper.
- -Sterilized by ETO, shelf life 5 years.
lt's a relatively invasive procedure and is performed by radiologist under guidance of imaging techniques such as ultrasound, X-ray.
This is a single-use device.
Not intended for use in bone.
6. Indication
It is to be used for taking cytological and histological biopsies of soft tissue.
7. Similarities and Differences of the Proposed Devices to the Predicate Devices
Promisemed Fine Biopsy Needle is substantially equivalent to the predicate device, Pan Aspirating Needle (Chiba), K970872 in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not affect the basic design principle, usage of the subject device.
| Items | Subject Device | Predicate Device
(K970872) | Comments |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Trade Name | Promisemed Fine Biopsy
Needle | Pan® Aspirating Needle (Chiba) | |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Gallini International, Inc. | |
| Device Class | Class II | Class II | Same |
| Product Code | KNW | KNW | Same |
| Regulation number | 876.1075 | 876.1075 | Same |
| Regulation Name | Instrument, biopsy | Instrument, biopsy | Same |
| Intended Use/
Indications for
Use | It is to be used for taking cytological
and histological biopsies of soft
tissue. | It is to be used for taking cytological
and histological biopsies of soft tissue. | Same |
| Operati
ng
Principl
e | It's a relatively invasive
procedure and is performed by
radiologist under guidance of
imaging techniques such as
ultrasound, X-ray. | It's a relatively invasive procedure
and is performed by radiologist
under guidance of imaging
techniques such as ultrasound, X-
ray. | Same |
| Materials | - Needle: Stainless Steel
(X5CrNi18-10);
- Needle base: Acrylonitrile
Butadiene Styrene (ABS); | - Needle: Stainless Steel
(X5CrNi18-10); - Needle base: Acrylonitrile
Butadiene Styrene (ABS); | Same |
A detailed comparison to the predicate is provided in Table 1.
6
| - Depth stop: Thermoplastic Elastomer (TPE); | - Depth stop: Thermoplastic Elastomer (TPE); | 510(K) Submission, K213083 | |||||
|---|---|---|---|---|---|---|---|
| Reuse durability | Single Use | Single Use | Same | ||||
| Performance: | |||||||
| Echogenic | Yes | Yes | Same | ||||
| Connector transparency | Transparent/lock | Transparent/lock | Same | ||||
| Needle Gauge | 16G, 18G, 19G, 20G, 21G, 22G, 23G | 18G, 20G, 21G, 22G, 23G, 25G | Subject device has two gauge sizes (16G, 19G) more than predicate device. | ||||
| The 16G OD of needle tube which providing more samples volume and reduce operation time during clinical procedure, therefore, introduce any new concerns for safety or efficacy. | |||||||
| Needle Length | 90mm, 100mm, 150mm, 200mm | 50mm, 80mm, 90mm, 150mm, 200mm | Different | ||||
| Subject device has less needle length than predicate device. | |||||||
| Inner needle hub color | Per ISO 6009: | ||||||
| White/16G, Pink/18G, Cream/19G, Yellow/20G, Light green/21G, Black/22G, Light blue/23G. | Per ISO 6009: | ||||||
| Pink/18G, Yellow/20G, Light green/21G, Black/22G, Light blue/23G, Orange/25G | Each color is in accordance with ISO 6009. | ||||||
| Needle tube tip type | Chiba | Chiba | Same | ||||
| Bond between outer needle tube and hub | according to the nominal OD of the outer needle, the outer needle and hub shall not break when pull the needle with the axial static force specified in the below table for 10s. | ||||||
| OD Force /N 23G 34 | Same | ||||||
| Bond between inner needle tube and hub | The inner needle and hub shall not break when pull the needle with the axial static force specified in the below table for 10s. | ||||||
| OD Force /N 23G 10 | Same | ||||||
| Needle tube performance | Per ISO 9626: | Per ISO 9626: | Same |
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| 510(k) Submission, K213083 | |||
|---|---|---|---|
| Fine Biopsy Needle | - Resistance to breakage; |
- Resistance to corrosion; | - Resistance to breakage;
- Resistance to corrosion; | |
| Scale identification | The scale line shall form a ring on the
outside of the needle tube and be
clearly discernible. The distance
from the tip of the inner needle to
the front edge of the first scale line
shall be 10mm±1.5mm as well as any
two adjacent tick marks | The scale line shall form a ring on the
outside of the needle tube and be
clearly discernible. The distance from
the tip of the inner needle to the front
edge of the first scale line shall be
10mm±1.5mm as well as any two
adjacent tick marks | Same |
| Lucer lock
Connector
performance | Per ISO 80369-7: - Positive pressure liquid leakage;
- Sub-atmospheric pressure air
leakage; - Stress cracking;
- Resistance to separation from
axial load; - Resistance to separation from
unscrewing; - Resistance to overriding; | Per ISO 80369-7:
- Positive pressure liquid leakage;
- Sub-atmospheric pressure air
leakage; - Stress cracking;
- Resistance to separation from axial
load; - Resistance to separation from
unscrewing; - Resistance to overriding; | Same |
| Sterilizatio
n method | EO Sterilization | EO Sterilization | Same |
| Shelf life | 5 years | 5 years | Same |
| Biocompatibility | Complied with ISO10993 series
standards, and the following
tests are performed - Cytotoxicity: No cytotoxicity;
- Skin Irritation: No evidence of
skin irritation; - Skin Sensitization: No evidence
of sensitization; - Acute Systemic Toxicity: No
systemic toxicity; | Complied with ISO10993 series
standards, and the following tests
are performed - Cytotoxicity: No cytotoxicity;
- Skin Irritation: No evidence of
skin irritation; - Skin Sensitization: No evidence
of sensitization; - Acute Systemic Toxicity: No
systemic toxicity; | Same |
| | - Pyrogen: Non pyrogenic: | - Pyrogen: Non pyrogenic: | |
Performance Testing Summary 8.
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Appearance;
- Cleanliness;
- Color code;
- Dimensions;
- Needle point;
- Patency of lumen;
- Tip structure;
8
- Bond between outer needle tube and hub;
- Bond between inner needle tube and hub;
- Sheath;
- Stiffness;
- Resistance to breakage;
- Resistance to corrosion;
- Scale identification;
- Positive pressure liquid leakage;
- Sub-atmospheric pressure air leakage;
- Stress cracking;
- Resistance to separation from axial load;
- Resistance to separation from unscrewing;
- Resistance to overriding;
The performance test results are indicated that performance of Fine Biopsy Needles meet the specific requirements. We concluded the proposed devices are substantially equivalent to the identified predicate devices in general appearance, dimension, needle tube performance, color, scale and connector.
9. Conclusion
Based on the information provided within this 510(k) submission, proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.