(306 days)
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle.
The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath.
It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath.
The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.
The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided text describes the regulatory clearance (510(k)) of a medical device, the "Disposable Biopsy Refill Needle," and focuses on demonstrating its substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical (bench) testing and comparison to an already cleared device, rather than extensive clinical studies for standalone or comparative effectiveness of an AI/human-in-the-loop system.
Therefore, many of the requested elements for an AI-based device (like MRMC studies, ground truth establishment for large datasets, sample sizes for training/test sets for machine learning models, and expert qualifications for data labeling) are not applicable to this specific traditional medical device clearance.
Here's an analysis based solely on the provided text:
Device: Disposable Biopsy Refill Needle
Regulatory Submission Type: 510(k) Premarket Notification (for substantial equivalence to a predicate device, not an AI/ML device)
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are generally established by meeting recognized consensus standards and demonstrating performance equivalent to the predicate device. The performance is reported as "Conformity has been demonstrated" for various tests.
| Test Item | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Tests | ||
| Depth projection | Subject device will not extend over the stylet tip during use. | Conformity has been demonstrated. |
| Penetration force | Equivalent to predicate device. | Conformity has been demonstrated. |
| Stiffness | Meet requirements per ISO 9626. | Conformity has been demonstrated. |
| Resistance to Breakage | Meet requirements per ISO 9626. | Conformity has been demonstrated. |
| Bonding Strength | Meet requirements per ISO 7864 for connection firmness. | Conformity has been demonstrated. |
| Biopsy Tissue Sample Testing | Successfully retrieve biopsy specimen multiple times. | Conformity has been demonstrated. |
| Ultrasound Visibility | Invasive part visible in guided area/ultrasound range. | Conformity has been demonstrated. |
| Biocompatibility | ||
| Cytotoxicity | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Sensitization | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Intracutaneous irritation | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Acute systemic toxicity | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Material mediated pyrogenicity | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Hemolysis | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Sterilization & Shelf Life | ||
| Sterility (EO) | SAL: 10-6, packaging maintains sterility per ISO 11607-1. | Successfully tested. |
| Shelf Life | Maintain safety and effectiveness for 3 years. | Label shelf life is 3 years. |
2. Sample sizes used for the test set and the data provenance
The document primarily discusses bench testing of a physical device. It does not refer to a "test set" in the context of a machine learning model, nor does it detail specific sample sizes for each bench test performed (e.g., how many needles were tested for penetration force). The data provenance is from non-clinical bench testing conducted by Suzhou Leapmed Healthcare Corporation. No country of origin for data is specified, as it's not a data-driven AI study. All tests are inherently retrospective as they are performed before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device clearance. There is no "ground truth" in the sense of expert annotation of medical images or data for an AI algorithm. Ground truth for a physical device is established through engineering and quality control measurements against pre-defined specifications and international standards (e.g., ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling disagreements among human readers/experts in AI model ground truth establishment or MRMC studies. For bench testing, results are quantitative or qualitative assessments against defined criteria, not subject to individual interpretation requiring adjudication.
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
There was no MRMC comparative effectiveness study done. The device is a physical biopsy needle, not an AI-assisted diagnostic or interventional system. The submission explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" (or basis for acceptance) is derived from:
- Engineering specifications and design requirements: For physical properties like dimensions, material strength, and performance characteristics (e.g., penetration force, stiffness).
- International consensus standards: Such as ISO 9626 (needles), ISO 10993 (biocompatibility), ISO 11607-1 (packaging/sterilization), and ISO 7864 (bonding strength).
- Comparative testing against a legally marketed predicate device: Demonstrating that the new device performs equivalently to a device already deemed safe and effective.
8. The sample size for the training set
This is not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Suzhou Leapmed Healthcare Corporation % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
July 6, 2022
Re: K212819
Trade/Device Name: Disposable Biopsy Refill Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: May 23, 2022 Received: June 6, 2022
Dear Boyle Wang:
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 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
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device reporting (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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website 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,
for
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) K212819
Device Name Disposable Biopsy Refill Needle
Indications for Use (Describe)
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Leapmed. The logo consists of the word "LEAPMED" in a serif font, with three curved lines above the "A" in "LEAPMED". Below the logo is the text "SUZHOU LEAPMED HEALTHCARE CORPORATION" in a smaller, sans-serif font.
510(k) Summary K212819
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Suzhou Leapmed Healthcare Corporation |
|---|---|
| Address: | Wuzhong Science Park, NO.2 & NO.3 Building, 38# North GuanduRoad, Wuzhong District, Suzhou City, 215100 Jiangsu,P.R.China |
| Tel: | (+86) 512 66554498-8043 |
| Contact: | Yu Zhu |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date Submitted: Jul.4,2022
2.0 Device Information
| Trade name: | Disposable Biopsy Refill Needle |
|---|---|
| Common name: | Biopsy Needle |
| Classification name: | Gastroenterology-urology biopsy instrument |
| Model(s): | A, B |
| Production code: | FCG |
| Regulation number: | 21 CFR 876.1075 |
| Classification: | Class II |
| Panel: | Gastroenterology/Urology |
3.0 Predicate Device Information
| Manufacturer: | M.D.L. S.r.l. |
|---|---|
| Device: | MDL Biopsy and Coaxial Introducer Needles |
| 510(k) number: | K160316 |
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4.0 Device Description
The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle.
The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath.
It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath.
The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.
The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
5.0 Indication for Use Statement
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures
6.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance testing Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 9626, ISO 10993-7, ISO 10993-1, ISO 11607-1. Results from testing performed confirms that the design requirement
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Image /page/5/Picture/1 description: The image shows the logo for LeapMed. The logo is in blue and features the word "LEAPMED" in a sans-serif font. Above the "MED" portion of the logo are three curved lines, resembling radio waves or a signal. The logo is simple and professional, likely representing a company in the medical or technology field.
SUZHOU LEAPMED HEALTHCARE CORPORATION
specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Disposable Biopsy Refill Needle is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 3 years.
7.2 Biocompatibility testing of Disposable Biopsy Refill Needle has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity and hemolysis. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable Biopsy Refill Needle is non-toxic and biocompatible.
7.3 Performance testing - Bench The performance of Disposable Biopsy Refill Needle has been verified. Tests as described in table 1 have been completed.
| Test Item | Description |
|---|---|
| Depth projection | To confirm that subject device will not extend over the stylet tip during use. Conformity has been demonstrated. |
| Penetration force | To confirm that the penetration force of the subject device is equivalent to predicate device. Conformity has been demonstrated. |
| Stiffness | To test the stiffness of the refill needle per ISO 9626. Conformity has been demonstrated. |
| Resistance to Breakage | To test the Resistance to Breakage per ISO 9626. Conformity has been demonstrated. |
| Bonding Strength | To test the Bonding Strength per ISO 7864 to confirm the connection firmness. Conformity has been demonstrated. |
| Biopsy Tissue SampleTesting | To confirm that the subject device can successfully retrieve biopsy specimen multiple times. Conformity has been demonstrated. Conformity has been demonstrated. |
| Ultrasound Visibility | To confirm that the invasive part of subject device is visible in the area guided by the puncture frame or within the ultrasound range. Conformity has been demonstrated. |
Table 1: Performance testing summary - Bench
7.0 _Summary of Clinical Testing
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
Table 2- Comparison of Technology Characteristics
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K212819 | K160316 |
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Image /page/6/Picture/0 description: The image shows the word "LEAPMED" in blue font. There are three curved lines above the "M" in "LEAPMED", which may be meant to represent radio waves. The font is a serif font.
K212819
SUZHOU LEAPMED HEALTHCARE CORPORATION
| Product Code | FCG | FCG |
|---|---|---|
| Regulation No. | 21 CFR 876.1075 | 21 CFR 876.1075 |
| Class | II | II |
| IntendedUse/Indication forUse | Disposable Biopsy Refill Needle isintended for soft tissue core biopsyfrom liver,kidney, prostate, breast,spleen, lymph nodes and varioussoft tissue masses. The device isnot intended for use in bone.The extent of histologicalabnormality cannot be reliablydetermined from itsmammographic appearance.Therefore the extent of removal ofthe imaged evidence of anabnormality does not predict theextent of removal of a histologicalabnormality (e.g. malignancy).When the sampled abnormality isnot histologically benign, it isessential that the tissue marginsbe examined for completeness ofremoval using standard surgicalprocedures. | MDL Biopsy Needle is intended forsoft tissue core biopsy with PaliumReusable Automatic BiopsyDevice. The device is not intendedfor use in bone. |
| Anatomical sites | Specimens from soft tissue suchas liver, kidney, prostate, breast,spleen, lymph nodes and varioussoft tissue masses | Specimens from soft tissue suchas liver,kidney, prostate, breast,spleen, lymph nodes and varioussoft tissue masses. |
| Mechanism ofAction | Single-hand automatic activation | one stage or two stage firingmode (user preference) |
| Device type | Automatic biopsy gun | Automatic biopsy gun |
| Visualization | Conventional imaging guidance | Conventional imaging guidance |
| technique | equipment excluding MRI | equipment excluding MRI |
| Needle material | Stainless Steel.Only Stainless steel is in directsurgical contact with all softtissues of the patient. | Stainless Steel |
| Needle diameter(Gauge) | 12G,14G,16G,18G,20G | 14G,16G,18G,20G |
| Needle length(mm) | 100,130,160,200 | 100,130,150,160,200,250,300 |
| CoaxialNeedleDiameter | 11G,13G,15G,17G,19G | 11G,13G,15G,17G,19G |
| (Gauge) | ||
| Coaxial Needlelength(mm) | 70,78,100,108,130,138,170,178 | 81,82,111,112,131,133,141,143,181,183,233,283 |
| Cannula andStylet | The cannula is designed with anouter cutting cannula having asharpened tip and an inner styletwith sample slot ( a 19mmspecimen notch). | The cannula is designed withan outer cutting cannula having asharpened tip and an inner styletwith sample slot( a 20 mmspecimen notch). |
| Color Depiction | Per ISO 6009:2016:Yellow= 20G, Pink= 18G, Purple=16 G, Green= 14G, Paleblue=12G | Not publicly available |
| NeedleAdvancementand TissueAccess | Biopsy Needle with guillotinecoring provide the clinician with thesame single automaticadvancement for fixed samplelength for tissue penetration andcutting. | Single or two-stage (sequential)automatic stylet advancement withdifferent needle designs |
| Activation force | Single-hand automatic activation | Sequential advancement system |
| Specimen notchsize | 19mm | 20mm |
| PenetrationDepth | 15mm, 22mm | 15mm,22mm |
| Sterile | Ethylene Oxide, SAL: 10-6 | Ethylene Oxide |
| Shelf Life | 3 years | 5 years |
| Single Use | Single Use | Single Use |
| Labeling | Conform with 21 CFR 801 | Conform with 21 CFR 801 |
| PerformanceComparisontesting | Comparative test of penetration force, stiffness, resistance to breakage,bonding strength and depth projection and tissue sample extractiontesting on the current subject device and the predicate device havebeen performed. | |
| Biocompatibility | Conform with ISO10993-1(ISO10993-4, ISO10993-5,ISO10993-10, ISO10993-11) | Conform with ISO 10993standards |
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Image /page/7/Picture/0 description: The image shows the logo for LeapMed. The logo is in blue and features the word "LEAPMED" in a serif font. Above the "M" in "LEAPMED" are three curved lines, resembling radio waves.
SUZHOU LEAPMED HEALTHCARE CORPORATION
The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:
• Same intended use (The intended use describe is different, but the actual intended use is the same since the predicate device is used with Palium Automatic Reusable
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K212819
SUZHOU LEAPMED HEALTHCARE CORPORATION
Biopsy Device,and the Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver,kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone.)
- Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- · Same fundamental technology/principal of operation/user interface
The disposable biopsy refill needle designs display minor differences between the subject device and the predicate devices for gauge and needle length,but the comparative performance testing results per FDA recognized standards ISO 9626 and ISO 7864 on the subject device and the predicate device shown there is no significant risk raised by the difference.
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K160316 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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.