(151 days)
It is to be used for taking cytological and histological biopsies of soft tissue.
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.
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.
The provided text describes a 510(k) submission for the Promisemed Fine Biopsy Needle. It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes that would typically be associated with medical device performance studies.
The section titled "Performance Testing Summary" mentions various bench tests conducted to verify the device's performance against the predicate device. These tests primarily focus on physical and mechanical characteristics relevant to the manufacturing quality and basic functionality of a biopsy needle, rather than clinical performance or diagnostic efficacy.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (Table 1) between the subject device (Promisemed Fine Biopsy Needle) and the predicate device (Pan® Aspirating Needle (Chiba), K970872). However, this table lists parameters of the device itself and manufacturing/material specifications, not acceptance criteria for clinical performance or diagnostic accuracy. The "Performance" section within the table lists "Echogenic" and "Connector transparency" and states "Same" in comparison to the predicate. The "Performance Testing Summary" lists a series of bench tests, but no specific numerical acceptance criteria or performance metrics (like accuracy, sensitivity, or specificity) are provided for these tests. The conclusion states: "The performance test results are indicated that performance of Fine Biopsy Needles meet the specific requirements." This is a general statement without specific data.
Table of Device Characteristics & Performance (from document)
| Items | Subject Device Performance/Characteristic | Predicate Device Performance/Characteristic | Comments / Acceptance |
|---|---|---|---|
| Performance (general) | |||
| Echogenic | Yes | Yes | Same (Implied acceptance: Yes) |
| Connector transparency | Transparent/lock | Transparent/lock | Same (Implied acceptance: Transparent/lock) |
| Reuse durability | Single Use | Single Use | Same (Implied acceptance: Single Use) |
| Material/Physical Properties | |||
| Needle Gauge | 16G, 18G, 19G, 20G, 21G, 22G, 23G | 18G, 20G, 21G, 22G, 23G, 25G | Subject device includes 16G, 19G; "do not 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 options); no impact on safety/efficacy implied. |
| Inner needle hub color | Per ISO 6009 | Per ISO 6009 | Each color in accordance with ISO 6009 (Implied acceptance: ISO 6009 compliance) |
| Needle tube tip type | Chiba | Chiba | Same (Implied acceptance: Chiba tip) |
| Bond between outer needle tube and hub | Meets axial static force (e.g., 23G 34 N) | (Not explicitly stated for predicate but "Same") | Implied acceptance: Meets specified axial static force for 10s |
| Bond between inner needle tube and hub | Meets axial static force (e.g., 23G 10 N) | (Not explicitly stated for predicate but "Same") | Implied acceptance: Meets specified axial static force for 10s |
| Needle tube performance | Per ISO 9626: Resistance to breakage; Resistance to corrosion | Per ISO 9626: Resistance to breakage; Resistance to corrosion | Same (Implied acceptance: ISO 9626 compliance) |
| Scale identification | Clearly discernible, 10mm±1.5mm from tip to first mark and between marks | Clearly discernible, 10mm±1.5mm from tip to first mark and between marks | Same (Implied acceptance: Meets specified scale identification) |
| Luer 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 (same list) | Same (Implied acceptance: ISO 80369-7 compliance) |
| Sterilization method | EO Sterilization | EO Sterilization | Same (Implied acceptance: EO Sterilization) |
| Shelf life | 5 years | 5 years | Same (Implied acceptance: 5 years) |
| Biocompatibility | Complied with ISO10993 series (Cytotoxicity, Skin Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogen) | Complied with ISO10993 series (same list) | Same (Implied acceptance: ISO10993 series compliance) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing" but does not specify sample sizes for these tests, nor does it refer to human or animal test sets. The provenance of the data is implied to be from the manufacturer (Promisemed Hangzhou Meditech Co., Ltd. in China) as they conducted the tests. Whether the tests were prospective (designed for this submission) or retrospective (using existing data) is not specified, but bench testing for a 510(k) is typically conducted prospectively for the submission.
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/Not provided. The testing described is bench testing of physical and mechanical properties, not a study requiring expert-established ground truth for a diagnostic or clinical outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical outcomes, which is not described here.
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
No MRMC comparative effectiveness study was mentioned or conducted. This device is a manual biopsy needle, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the bench tests performed, the "ground truth" would be the engineering specifications and ISO standards referenced (e.g., ISO 9626 for needle tube performance, ISO 6009 for color codes, ISO 80369-7 for connector performance).
8. The sample size for the training set
Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
In summary: The provided document is a 510(k) premarket notification for a physical medical device (biopsy needle). The "performance" assessment focuses on showing that the device's physical and mechanical properties are substantially equivalent to a predicate device through bench testing and compliance with recognized standards. It does not present clinical performance data (like diagnostic accuracy, sensitivity, or specificity) or studies involving human subjects, therefore, many of the requested elements pertaining to such studies are not present in the document.
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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
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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
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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
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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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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. -
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- 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 BiopsyNeedle | Pan® Aspirating Needle (Chiba) | |
| Manufacturer | Promisemed HangzhouMeditech 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 forUse | It is to be used for taking cytologicaland histological biopsies of softtissue. | It is to be used for taking cytologicaland histological biopsies of soft tissue. | Same |
| OperatingPrinciple | It's a relatively invasiveprocedure and is performed byradiologist under guidance ofimaging techniques such asultrasound, X-ray. | It's a relatively invasive procedureand is performed by radiologistunder guidance of imagingtechniques such as ultrasound, X-ray. | Same |
| Materials | - Needle: Stainless Steel(X5CrNi18-10);- Needle base: AcrylonitrileButadiene Styrene (ABS); | - Needle: Stainless Steel(X5CrNi18-10);- Needle base: AcrylonitrileButadiene Styrene (ABS); | Same |
A detailed comparison to the predicate is provided in Table 1.
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| - 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 | DifferentSubject 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 theoutside of the needle tube and beclearly discernible. The distancefrom the tip of the inner needle tothe front edge of the first scale lineshall be 10mm±1.5mm as well as anytwo adjacent tick marks | The scale line shall form a ring on theoutside of the needle tube and beclearly discernible. The distance fromthe tip of the inner needle to the frontedge of the first scale line shall be10mm±1.5mm as well as any twoadjacent tick marks | Same |
| Lucer lockConnectorperformance | Per ISO 80369-7:- Positive pressure liquid leakage;- Sub-atmospheric pressure airleakage;- Stress cracking;- Resistance to separation fromaxial load;- Resistance to separation fromunscrewing;- Resistance to overriding; | Per ISO 80369-7:- Positive pressure liquid leakage;- Sub-atmospheric pressure airleakage;- Stress cracking;- Resistance to separation from axialload;- Resistance to separation fromunscrewing;- Resistance to overriding; | Same |
| Sterilization method | EO Sterilization | EO Sterilization | Same |
| Shelf life | 5 years | 5 years | Same |
| Biocompatibility | Complied with ISO10993 seriesstandards, and the followingtests are performed- Cytotoxicity: No cytotoxicity;- Skin Irritation: No evidence ofskin irritation;- Skin Sensitization: No evidenceof sensitization;- Acute Systemic Toxicity: Nosystemic toxicity; | Complied with ISO10993 seriesstandards, and the following testsare performed- Cytotoxicity: No cytotoxicity;- Skin Irritation: No evidence ofskin irritation;- Skin Sensitization: No evidenceof sensitization;- Acute Systemic Toxicity: Nosystemic 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;
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- 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.
§ 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.