(112 days)
Not Found
No
The description focuses on the mechanical aspects of a biopsy instrument and does not mention any AI or ML components or functions.
No.
The device is used for obtaining biopsies, which is a diagnostic procedure to collect tissue samples, not to treat or alleviate a medical condition.
Yes
The device is a biopsy instrument, used to obtain tissue samples for diagnosis. This makes it a diagnostic device as it aids in the process of identifying a disease or condition.
No
The device description clearly details a physical, mechanical instrument with components like canula, stylet, protecting sheath, and mechanical powering parts, designed for obtaining tissue biopsies. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain biopsies from soft tissues. This is a procedure performed on the patient to collect a sample.
- Device Description: The device is a biopsy instrument designed for physically extracting tissue. It is used in conjunction with imaging modalities (CT and ultrasound) to guide the procedure.
- Lack of In Vitro Activity: An IVD is a device used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device's primary function is the collection of the specimen, not the analysis of it.
The device is a surgical instrument used for a biopsy procedure, which is an in vivo (within the body) process. The collected tissue sample could then be used in an IVD test, but the biopsy instrument itself is not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.
Product codes
KNW
Device Description
The disposable automatic core biopsy instrument is divided into QZDA and QZDB in accordance with different configuration. QZDA contains automatic core biopsy instrument. QZDB contains automatic core biopsy instrument and coaxial biopsv needle.
The disposable automatic core biopsy instrument QZDA contains automatic core biopsy instrument and QZDB contains automatic core biopsy instrument and coaxial biopsy needle. The automatic core biopsy instrument consists of canula, stylet, protecting sheath and mechnical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet, stylet housing and protecting sheath.
The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. Both the QZDA and QZDB 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, and green= 14G). The needles have a protecting sheath.
The disposable automatic core biopsy instrument is a spring-loaded automatic biopsy needle that is visible in CT (computed tomography) and 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 automatic core biopsy instrument are 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (computed tomography), ultrasound
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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.
Key results from bench testing (Table 1):
- Depth projection: To confirm that subject device will not extend over the stylet tip (over-throw) 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.
- Loading force: To confirm that the force to activate the subject device (release the spring) is not too low, resulting in unintentional activation during use. Conformity has been demonstrated.
- Mechanical durability: To confirm that subject device withstands the forces applied to the subject device during normal use. Conformity has been demonstrated.
- Tissue sample extraction test: To confirm that the subject device can successfully retrieve biopsy specimen multiple times. Conformity has been demonstrated.
- Tip configuration: To confirm that it is possible to take a biopsy specimen closer to nearby sensitive anatomy/structure compared to predicate device. Subject device shall have a tip dead-space that is shorter compared to predicate device. 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.
- Compatibility: To confirm that the device is compatible with coaxial needle standardized sizes as per ISO 9626 has been applied.
- Qualification metal tubing/needle component: The stainless-steel tubing fulfills the requirement in ISO 9626 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods. Conformity has been demonstrated.
No clinical study is included in this submission.
Key Metrics
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.
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November 10, 2021
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
Re: K212284
Trade/Device Name: Disposable Automatic Core Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: August 11, 2021 Received: August 16, 2021
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
for Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212284
Device Name
Disposable Automatic Core Biopsy Instrument
Indications for Use (Describe)
The Disposable Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.
| 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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510(k) Summary (K212284)
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 Guandu Road, |
| Wuzhong District, Suzhou City, 215100 Jiangsu, P.R.China | |
| Tel: | (+86) 512 66554498-8043 |
| Contact: | Yu Zhu |
Designated Submission Correspondent
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
|---|---|
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China |
| Tel: | +86-21-50313932 |
| Contact: | Mr. Boyle Wang |
| Email: | Info@truthful.com.cn |
Date of Preparation: Oct.27,2021
2.0 Device Information
Trade name: Disposable Automatic Core Biopsy Instrument Common name: Disposable Automatic Core Biopsy Instrument Classification name: Gastroenterology-urology biopsy instrument. QZDA, QZDB Model(s): Production code: KNW Regulation number: 21 CFR 876.1075 Classification: Class II Panel: Gastroenterology/Urology
3.0 Predicate Device Information
Manufacturer: Bard Peripheral Vascular, Inc. Device: Bard® Monapty® Disposable Core Biopsy Instrument Bard® Max-Coreo® Disposable Care Biopsy Instrument 510(k) number: K133948
4
4.0 Device Description
The disposable automatic core biopsy instrument is divided into QZDA and
QZDB in accordance with different configuration. QZDA contains automatic core biopsy instrument. QZDB contains automatic core biopsy instrument and coaxial biopsv needle.
The disposable automatic core biopsy instrument QZDA contains automatic core biopsy instrument and QZDB contains automatic core biopsy instrument and coaxial biopsy needle. The automatic core biopsy instrument consists of canula, stylet, protecting sheath and mechnical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet, stylet housing and protecting sheath.
The subject device is a single use full core biopsy device. It is available
in several gauge sizes and lengths. Both the QZDA and QZDB 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, and green= 14G). The needles have a protecting sheath.
The disposable automatic core biopsy instrument is a spring-loaded automatic biopsy needle that is visible in CT (computed tomography) and 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 automatic core biopsy instrument are 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
The Disposable Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.
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
5
specification and user needs have been met. The subject device is confirmed to be as safe and as effective as the predicate.
7.1 Sterilization and shelf life: Disposable automatic core biopsy instrument is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 3 years.
7.2 Biocompatibility testing: Disposable automatic core biopsy instrument has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable automatic core biopsy instrument concludes that disposable automatic core biopsy instrument is non-toxic and biocompatible.
7.3 Performance testing - Bench: The performance of disposable automatic core biopsy instrument 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 (over-throw) 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. | ||
| Loading force | To confirm that the force to activate the subject device | |
| (release the spring) is not too low, resulting in | ||
| unintentional activation during use. Conformity has been | ||
| demonstrated. | ||
| Mechanical durability | To confirm that subject device withstands the forces | |
| applied to the subject device during normal use. | ||
| Conformity has been demonstrated. | ||
| Tissue sample extraction | ||
| test | To confirm that the subject device can successfully | |
| retrieve biopsy specimen multiple times. Conformity has | ||
| been demonstrated | ||
| Tip configuration | To confirm that it is possible to take a biopsy specimen | |
| closer to nearby sensitive anatomy/structure compared to | ||
| predicate device. Subject device shall have a tip | ||
| dead-space that is shorter compared to predicate device. | ||
| 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. | ||
| Compatibility | To confirm that the device is compatible with coaxial | |
| needle standardized sizes as per ISO 9626 has been |
Table 1: Performance testing summary - Bench
6
| applied. | |
|---|---|
| Qualification metal | |
| tubing/needle | |
| component | The stainless-steel tubing fulfills the requirement in ISO 9626 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods. |
| Conformity has been demonstrated |
7.0 _Summary of Clinical Testing
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K212284 | K133948 |
| Product Code | KNW | KNW |
| Regulation No. | 21 CFR 876.1075 | 21 CFR 876.1075 |
| Class | II | II |
| Intended Use | The Disposable Automatic Core | |
| Biopsy Instrument is intended for | ||
| use in obtaining biopsies from soft | ||
| tissues such as liver, kidney, | ||
| prostate, spleen, lymph nodes and | ||
| various soft tissue tumors. It is not | ||
| Intended for use in bone. | The core needle biopsy device is | |
| intended for use in obtaining | ||
| biopsies from soft tissues such as | ||
| liver, kidney, prostate, spleen, | ||
| lymph nodes and various soft | ||
| tissue tumors. It is not intended | ||
| for use in bone. | ||
| Anatomical | ||
| sites | Specimens from soft tissue such | |
| as liver, kidney, prostate, spleen, | ||
| lymph nodes and various soft | ||
| tissue tumors. | Specimens from soft tissue such | |
| as liver, kidney, prostate, | ||
| spleen, lymph nodes and various | ||
| soft tissue tumors. | ||
| Mechanism of | ||
| Action | Single puncture and sample | |
| multiple times | Single puncture and sample | |
| multiple times | ||
| Device type | Automatic biopsy gun, | |
| spring-operated | Automatic biopsy gun, | |
| spring-operated | ||
| Visualization | ||
| technique | Conventional imaging guidance | |
| equipment excluding MRI | Conventional imaging guidance | |
| equipment excluding MRI | ||
| Needle material | Stainless Steel. | |
| Only Stainless steel is in direct | ||
| surgical contact with all soft | ||
| tissues of the patient. | Stainless Steel | |
| Needle | ||
| diameter | ||
| (Gauge) | 14G,16G,18G,20G | 14G,16G,18G,20G |
| Needle length | ||
| (mm) | 100,160,200,250 | 100,160,200,250 |
| Color | ||
| Depiction | Per ISO 6009:2016: | |
| Yellow= 20G, Pink= 18G, Purple= | ||
| 16 G, and Green= 14G | Per ISO 6009:2016: | |
| Yellow = 20G, Pink = 18G, Purple = 16G and Green = 14 G. | ||
| Cannula and | ||
| Stylet | The cannula is designed with an | |
| outer cutting cannula having a | ||
| sharpened tip and an inner stylet | ||
| with sample slot. | Not publicly available | |
| Needle | ||
| Advancement | ||
| and Tissue | ||
| Access | Biopsy Needle with guillotine | |
| coring provide the clinician with | ||
| the same single automatic | ||
| advancement for fixed sample | ||
| length for tissue penetration and | ||
| cutting. | Not publicly available | |
| Activation force | Single-hand automatic activation | Not publicly available |
| Specimen notch | ||
| size | 18mm | 18mm,19mm |
| Penetration | ||
| Depth | 22mm | 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 |
| Performance | ||
| Comparison | ||
| testing | Stiffness, Resistance to breakage, | |
| Resistance to corrosion, Sample | ||
| collection space and smoothness, | ||
| Connection firmness, Pressing | ||
| parts/Pressing parts firing force, | ||
| Cannula firing force, Sampling | ||
| switch, Scale marks firmness, | ||
| Total heavy metal content, Scale | ||
| mark identification, Sampling | ||
| structure, Penetration force, | ||
| Biopsy Sample Testing, | ||
| Ultrasound Visibility Testing | Stiffness, Resistance to breakage, | |
| Resistance to corrosion, Sample | ||
| collection space and smoothness, | ||
| Connection firmness, Pressing | ||
| parts, Pressing parts firing force, | ||
| Cannula firing force, Safety switch, | ||
| Sampling switch, Scale marks | ||
| firmness, Total heavy metal | ||
| content, Scale mark identification, | ||
| Sampling structure, Penetration | ||
| force, Biopsy Sample Testing, | ||
| Ultrasound Visibility Testing | ||
| Biocompatibility | Conform with ISO10993-1 | |
| (ISO10993-4, ISO10993-5, | ||
| ISO10993-10, ISO10993-11) | Conform with ISO 10993 | |
| standards |
Table 2- Comparison of Technology Characteristics
7
The technological characteristics of the subject device are identical to those of
8
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
- · 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 device needle designs display minor differences between the subject device and the predicate devices for specimen notch size and shelf life. The specimen notch size of the current device covered by the predicate device, also the validation report of shelf life shown the life time 3 years of the current device is scientific, reliable and effective. So we think the differences would not affect the substantial equivalence of the proposed device.
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 K133948 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.