(255 days)
Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.
The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The provided document describes the acceptance criteria and the study that proves the performance of the Single Use Grasping Forceps (K191900).
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Functional Performance | |
| Appearance | Met requirements |
| Dimensions | Met requirements |
| Jaws open wide | Tested (4.5mm, 8.5mm, 7mm, 8.2mm, similar to predicate devices with 6.3mm, 8.1mm, 10mm) - "results are all meet the requirements." |
| Grasping jaws opened and closed performance and compatibility with endoscope channel | Met requirements |
| Handle to core wire tensile strength | Met requirements |
| Clamping strength | Met requirements |
| Jaws misalignment test | Met requirements |
| Sterilization & Packaging | |
| EO residual | Met criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7 Second Edition 2008-10-15. |
| Shelf-life | Validated for three years in accelerated testing according to ASTM F1980-16 (2016). Essential performance achieved before and after shelf life test. Requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 also met. |
| Biocompatibility | |
| Cytotoxicity | Performed and demonstrated biocompatibility in accordance with FDA Guidance, "Use of International Standard ISO 10993-1..." |
| Sensitization | Performed and demonstrated biocompatibility. |
| Intracutaneous irritation test | Performed and demonstrated biocompatibility. |
| Complies with Standards | |
| Packaging, Seal Strength, Seal Leaks, Integrity of Seals, Internal Pressurization, Microbiological methods, Sterility Tests, Bacterial endotoxins test, Ethylene oxide sterilization, Biological evaluation of medical devices (cytotoxicity, residuals, irritation, skin sensitization) | Complied with: EN868-5:2018, ASTM F88/F88M-15, ASTM F1929-15, ASTM F1140/F1140M-13, ISO 11737-1, ASTM F1886/F1886M-16, ASTM F1980-16, ISO 10993-5, ISO 10993-7, ISO 10993-10, USP 37 NF 32:2014 <71>, USP 37-NF 32:2014 <85>, ISO 11135. |
2. Sample size used for the test set and the data provenance:
The document mentions "performance test bench" and "Non clinical tests were conducted," indicating laboratory-based testing rather than clinical data from human subjects. As such, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size of human subjects doesn't directly apply here. The tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The study involves non-clinical bench testing and compliance with established standards for device performance, sterilization, and biocompatibility. There is no "ground truth" established by human experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable, as the study is not based on expert adjudication of clinical findings.
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:
This information is not applicable. This is a 510(k) submission for a medical device (grasping forceps), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the fulfillment of established engineering specifications, performance standards (e.g., tensile strength, clamping strength, jaws opening/closing), and regulatory compliance as defined by international standards (ISO, ASTM, EN, USP) and FDA guidance for medical devices.
8. The sample size for the training set:
This information is not applicable. There is no concept of a "training set" as this is not an AI/machine learning model. The devices are manufactured and tested against predefined specifications.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains 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 acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name "U.S. Food & Drug Administration" is written in blue text.
March 27, 2020
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long RA Manager 301B, No. 22, XinYan Road Hanzhou, 311100 CHINA
K191900 Re: Trade/Device Name: Single Use Grasping Forceps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCZ Dated: February 25, 2020 Received: February 25, 2020
Dear Lucius Long:
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
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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 mediation-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,
Shanil P. Haugen, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K191900
Device Name Single Use Grasping Forceps
Indications for Use (Describe)
Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.
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 D) |
ption 000 (Part 21 SFAR 881 Support B)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in shades of green and blue, with Chinese characters above the company name. The company name "MEDNOVA" is written in green, and the full company name is written in black below the logo.
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Section 2 510(k) Summary( 21CFR 807.92)
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China
Contact person: Lucius.Long Telephone: 86-571-89167088 Fax: 86-571-89167086
2. Device
Name of the device: Single Use Grasping Forceps Classification name: Endoscope and Accessories per 21 CFR 876.1500 Regulation class: 2 Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: OCZ
3. Predicative device
3.1) 510(k) Number: K152802, Product Name: Grasping Forceps 3.2) 510(k) Number: K120084, Product Name: The US Endoscopy Endoscopic Retrieval Device
4. Device description
The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
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Image /page/4/Picture/0 description: The image shows the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in shades of green and blue, with Chinese characters above the English name "MEDNOVA". The full company name, "Zhejiang Chuangxiang Medical Technology Co.,Ltd", is printed in black text below the logo.
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5. Indications for use
Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag and remove tissue or foreign particle during endoscopic procedures.
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Image /page/5/Picture/0 description: The image shows a logo for MEDNOVA. The logo consists of a hexagon shape with a white design inside, and the text "MEDNOVA" is written in blue and green. To the right of the logo are Chinese characters in blue.
Zhejiang Chuangxiang Medical Technology Co.,Ltd
6. Technological Characteristics
The Single Use Grasping Forceps incorporates substantials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended in the predicate devices. It determined to be Substantially Equivalent to the predicate devices.
Comparison to predicate Devices:
| Item | Proposed device | Primary Predicate device | Additional Predicate device | Comparison toPredicate Devices |
|---|---|---|---|---|
| Device name | Single Use GraspingForceps | Grasping Forceps | The US EndoscopyEndoscopic Retrieval Device | / |
| 510(k) number | K191900 | K152802 | K120084 | / |
| Manufacturer | Zhejiang ChuangxiangMedical Technology Co., LTD. | MICRO-TECH (NANJING)CO., LTD. | UNITED STATESENDOSCOPY GROUP, INC. | / |
| Product Code | OCZ | OCZ | OCZ | Same |
| Regulation No. | 876.1500 | 876.1500 | 876.1500 | Same |
| Class | 2 | 2 | 2 | Same |
| Indications forUse | Single Use Grasping Forcepsare indicated for use ingastrointestinal tract of thepatient to grasp, clip, dragand remove tissue or foreignparticle during endoscopicprocedures. | Grasping Forceps device isintended to be used to grasptissue, retrieve foreign bodies,and remove tissue from withinthe gastrointestinal tract. | The US EndoscopyEndoscopic RetrievalDevice is intended to beused to grasp tissueand/or retrieve foreignbodies, excised tissueand stents duringendoscopic procedures. | Similar |
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Image /page/6/Picture/0 description: The image contains a logo with a geometric shape on the left, resembling a stylized hexagon with lines inside, colored in a gradient from green to blue. To the right of the geometric shape, there is text in both English and Chinese. The English text reads "MEDNOVA" with "MED" in blue and "NOVA" in green. Above the English text, there are three Chinese characters in blue, arranged horizontally.
Zhejiang Chuangxiang Medical Technology Co.,Ltd
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| Supplied Sterile | Yes | Yes | Yes | Same |
|---|---|---|---|---|
| Sterilizationmethod | EO | EO | EO | Same |
| Jaws open wide | 4.5mm, 8.5mm,7mm,8.2mm | 6.3mm,8.1mm | 10mm | Similar |
| Working Length | 1800mm, 2300mm | 1800mm,2300mm | 2300mm | Similar |
| Configuration | Jaws, Spring sheath,Finger ring | Jaws, Spring sheath,Finger ring | Jaws, Spring sheath,Finger ring | Same |
| Single Use | Yes | Yes | Yes | Same |
| Packaging | Single-use EO sterilized pouchwith one device per pouch | Single-use EO sterilized pouchwith one device per pouch | Single-use EO sterilizedpouch with one device perpouch | Same |
| Shelf Life | Three years | Five years | Three years | Similar |
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Image /page/7/Picture/0 description: The image shows the logo for MEDNOVA. The logo consists of a blue and green hexagon shape on the left, followed by the company name in blue and green text. The text is in both English and Chinese.
ng Medical Technology Co.,Ltd
7. Performance data
The devices Single Use Grasping Forceps has undergo performance test bench and compared with the predicate device, the results are all meet the requirements. The following bench tests were performed on the Single Use Grasping Forceps: Appearance;
Appearance,
Dimensions
Dimension;
Jaws open wide;
The Grasping jaws opened and closed performance and compatibility with endoscope channel;
Handle to core wire tensile strength;
Clamping strength;
Jaws misalignment test.
The testing performed demonstrated that the proposed and predicate devices are substantial equivalent.
The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7 Second Edition 2008-10-15. The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed in accordance with the FDA Guidance," Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. The cytotoxicity, sensitization and intracutaneous irritation test were performed to demonstrate the biocompatibility of the device.
8. Non-Clinical Test Conclusion:
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent(SE) to the predicate device.
The test results demonstrated the proposed device complies with the following standards:
EN868-5:2018, Packaging for terminally sterilized medical devices-Part 5: Sealable pouches and reels of porous materials and plastic film construction- Requirements and test methods.
ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-15, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
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Image /page/8/Picture/0 description: The image contains a logo for a company called MEDNOVA. The logo consists of a geometric shape on the left, resembling a stylized hexagon with a gradient fill of green and blue. To the right of the shape, the text "MEDNOVA" is written in a combination of blue and green. Above the company name are three blue Chinese characters.
ng Medical Technology Co.,Ltd
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ASTM F1140/F1140M-13, Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages. ISO 11737-1 Third Edition 2018-01 Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microoranisms on product. ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection. ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. ISO 10993-5 Third Edition 2009-06-01 Biological evaluation of medical devices- part 5 tests for In Vitro Cytotoxicity. ISO 10993-7 Second Edition 2008-10-15 Biological evaluation of medical devices-Part 7 Ethylene oxide sterilization residuals [Including: Technical corrigendum 1(2009)].
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization.
USP 37 NF 32:2014 <71> Sterility Tests
USP 37-NF 32:2014 <85> Bacterial endotoxins test
ISO 11135 Second Edition 2014 -07-15 Sterilization of health care products —
Ethylene oxide — Requirements for development, validation and routine
control of a sterilization process for medical devices
9. Substantially Equivalent Conclusion
Based on the technological characteristics and overall performance of the devices in the bench testing, there are no significant differences exist between the proposed devices and the predicate devices, the proposed devices do not raise any new issues of safety and effectiveness, and the performances as well as the predicate device. It is determine that the proposed devices and the predicate devices are substantially equivalent.
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.