(306 days)
The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung 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 semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle.
The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing 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, and green= 14G). The needles have a protecting sheath.
The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that 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. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen.
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 semi automatic 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.
This document describes acceptance criteria and testing for the Disposable Semi Automatic Biopsy Instrument (K212820) by Suzhou Leapmed Healthcare Corporation.
Acceptance Criteria and Device Performance Study
The acceptance criteria for the Disposable Semi Automatic Biopsy Instrument are based on non-clinical testing, particularly bench testing, to assess performance and functionality against requirement specifications and recognized consensus standards. The study demonstrates that the device performs equivalently to its predicate device (SemiCut Semi-automatic Biopsy Needle, K160316) and meets safety and effectiveness requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria / Standard Compliance | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11607-1 (for sterile barrier systems), SAL: 10-6 | Successfully tested, delivered sterile, shelf life of 3 years. |
| Biocompatibility | ISO 10993 (Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity) | Test results verify that ISO 10993 criteria are fulfilled. Concluded as non-toxic and biocompatible. |
| Depth projection | Device will not extend over the stylet tip during use. | Conformity demonstrated. |
| Penetration force | Equivalent to predicate device. | Conformity demonstrated. |
| Stiffness | Per ISO 9626. | Conformity demonstrated. |
| Resistance to Breakage | Per ISO 9626. | Conformity demonstrated. |
| Bonding Strength | Per ISO 7864 (connection firmness). | Conformity demonstrated. |
| Biopsy Tissue Sample | Successfully retrieve biopsy specimen multiple times. | Conformity demonstrated. |
| Ultrasound Visibility | Invasive part visible in the area guided by puncture frame or within ultrasound range. | Conformity demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each bench test. However, it indicates that "bench testing was performed" and "results from testing performed confirms that the design requirement specification and user needs have been met." The tests involved evaluating the subject device against technical specifications and sometimes comparing it directly with the predicate device.
The data provenance is non-clinical bench testing conducted by the manufacturer, Suzhou Leapmed Healthcare Corporation. No information regarding country of origin for the test data itself is given beyond the company's location in China. The testing is reported as retrospective in the sense that it evaluates the manufactured device against pre-defined specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. The ground truth for the bench testing is established by compliance with international standards (ISO 9626, ISO 10993, ISO 11607, ISO 7864) and manufacturer's design specifications. No human expert "ground truth" in the diagnostic sense is required for these mechanical and material tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined criteria in established international standards. There is no human interpretation or adjudication in the typical sense (e.g., 2+1, 3+1 consensus) as would be the case for clinical image interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission." This device gained clearance based on non-clinical (bench) testing and substantial equivalence to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical instrument (biopsy instrument), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Engineering specifications: The device's design requirements, such as depth projection and bonding strength.
- International Consensus Standards: ISO 9626 (Stiffness, Resistance to Breakage), ISO 10993 (Biocompatibility), ISO 11607-1 (Sterilization and Shelf Life), ISO 7864 (Bonding Strength).
- Functional requirements: The ability to successfully retrieve biopsy specimens and ultrasound visibility.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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: K212820
Trade/Device Name: Disposable Semi Automatic Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: May 26, 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
July 6, 2022
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212820
Device Name Disposable Semi Automatic Biopsy Instrument
Indications for Use (Describe)
The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Leapmed. The logo consists of the word "LEAPMED" in a serif font, with three curved lines above the "M" to represent radio waves. Below the logo is the text "SUZHOU LEAPMED HEALTHCARE CORPORATION" in a smaller, sans-serif font.
510(k) Summary K212820
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# NorthGuandu Road, 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,200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Jul.4, 2022 Date submitted:
2.0 Device Information
| Trade name: | Disposable Semi Automatic Biopsy Instrument |
|---|---|
| Common name: | Biopsy Instrument |
| Classification name: | Gastroenterology-urology biopsy instrument. |
| Model(s): | A, B |
| Production code: | KNW |
| Regulation number: | 21 CFR 876.1075 |
| Classification: | Class II |
| Panel: | Gastroenterology/Urology |
3.0 Predicate Device Information
Manufacturer: M.D.L. S.r.I. Device: SemiCut Semi-automatic Biopsy Needle
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Leapmed, a healthcare corporation based in Suzhou. The text below the logo reads "SUZHOU LEAPMED HEALTHCARE CORPORATION". The 510(k) number is listed as K160316.
4.0 Device Description
The disposable semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle.
The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing 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, and green= 14G). The needles have a protecting sheath.
The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that 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. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen.
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 semi automatic 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 Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung 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
{5}------------------------------------------------
Image /page/5/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 or a signal. The logo is simple and professional.
SUZHOU LEAPMED HEALTHCARE CORPORATION
(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 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 semi automatic 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 of disposable semi automatic 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 semi automatic 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 thestylet tip during use. Conformity has beendemonstrated. |
| Penetration force | To confirm that the penetration force of the subjectdevice is equivalent to predicate device. Conformityhas 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 confirmthe connection firmness. Conformity has beendemonstrated. |
| Biopsy Tissue Sample | To confirm that the subject device can successfully |
Table 1: Performance testing summary - Bench
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for LeapMed. The logo consists of the word "LEAPMED" in a serif font, with the letters in a dark blue color. Above the "M" in "LEAPMED" are three curved lines, resembling radio waves or a signal. The logo is simple and professional, and the curved lines add a touch of modernity.
K212820
SUZHOU LEAPMED HEALTHCARE CORPORATION
| Testing | 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. |
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. | K212820 | K160316 | |
| Product Code | KNW | KNW | |
| Regulation No. | 21 CFR 876.1075 | 21 CFR 876.1075 | |
| Class | II | II | |
| Intended Use | The Disposable Semi AutomaticBiopsy Instrument is intended forobtaining percutaneous or surgicalhistological core samples from softtissues such as breast, kidney,liver, lung and various soft tissuemasses. The device is notintended 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 surgical | SemiCut Semi-Automatic BiopsyNeedle is intended for obtainingpercutaneous or surgicalhistological core samples from softtissues such as breast, kidney,liver, lung and various soft tissuemasses. The device is notintended for use in bone. | |
| procedures | |||
| Anatomicalsites | Specimens from soft tissue suchas breast, kidney, liver, lung andvarious soft tissue masses | Specimens from soft tissue suchas breast, kidney, liver, lung andvarious soft tissue masses. | |
| Mechanism ofAction | Single-hand semi-automaticactivation | Single-hand semi-automaticactivation | |
| Device type | Semi Automatic biopsy gun | Semi Automatic biopsy gun | |
| Visualizationtechnique | Conventional imaging guidanceequipment excluding MRI | Conventional imaging guidanceequipment excluding MRI | |
| Needle material | Stainless Steel.Only Stainless steel is in directsurgical contact with all softtissues of the patient. | Stainless Steel | |
| Needlediameter(Gauge) | 14G,16G,18G,20G | 14G,16G,18G | |
| Needle length(mm) | 60,100,130,160,200,250 | 70,90,100,110,120,150,160,200,250,300 | |
| Coaxial Needlediameter(Gauge) | 13G,15G,17G,19G | 13G,15G,17G,19G | |
| Coaxial Needlelength(mm) | 70,78,100,108,130,138,170,178 | 52,53,72,73,82,83,93,132,133,143,160,182,183,184,233 | |
| ColorDepiction | Per ISO 6009:2016:Yellow= 20G, Pink= 18G, Purple=16 G, and Green= 14G | Not publicly available | |
| 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 with anouter cutting cannula having asharpened tip and an inner styletwith sample slot( a 20mmspecimen notch). | |
| 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 | Single-hand automatic activation | |
| Specimen notchsize | 10mm,20mm | 10mm,20mm | |
| PenetrationDepth | 10mm,20mm | 10mm,20mm | |
| 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(ISO10993-4,ISO10993-5,ISO10993-10, ISO10993-11) | Conform with ISO 10993standards |
Table 2- Comparison of Technology Characteristics
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "LEAPMED" in blue font. Above the "MED" portion of the word, there is a symbol that looks like three curved lines, stacked on top of each other. The font is a serif font, and the overall image is simple and clean.
SUZHOU LEAPMED HEALTHCARE CORPORATION
{8}------------------------------------------------
Image /page/8/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. The logo is simple and professional.
K212820
OU 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
- · 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 gauge and needle length. The Max Needle gauge of the current device are bigger than those of the predicate device, 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.