(115 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing or data analysis.
No.
The device is described as grasping forceps intended to grasp tissue, retrieve foreign bodies, and remove tissue, which are diagnostic or procedural functions rather than therapeutic.
No
Explanation: The device, Grasping Forceps, is described as a tool for physical manipulation (grasping tissue, retrieving foreign bodies, removing tissue) within the gastrointestinal tract. Its intended use does not involve diagnosing conditions or identifying diseases.
No
The device description clearly outlines physical components (jaws, spring sheath, handle) and manufacturing processes (sterilization, packaging), indicating it is a hardware medical 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 "grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract." This describes a device used within the body for mechanical manipulation of tissue and objects.
- Device Description: The description details a physical tool with jaws, a sheath, and a handle, designed to pass through an endoscope. This is consistent with a surgical or interventional device.
- Lack of IVD Characteristics: An IVD is a device used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information about a patient's health. The description does not mention any analysis of samples or diagnostic testing.
- Performance Studies: The performance studies listed are related to the physical properties, sterility, and biocompatibility of the device, not the accuracy or performance of a diagnostic test.
Therefore, the Grasping Forceps device described is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
Product codes (comma separated list FDA assigned to the subject device)
OCZ
Device Description
The proposed device Grasping Forceps is a sterile, single-use device, designed to pass through a 2.8 mm or greater working channel of an endoscope.
The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.
The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 that the proposed device complies with the following standards:
ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
ASTM F1140/F1140M-13, Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages.
ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices -Microbiological methods-Part 1: Determination of a population of microorganisms on products
ASTM F1886/F1886M-09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
AAMI ANSI ST72:2011 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing.
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. ISO 10993-7:2008(R) 2012, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. USP 37 NF 32: 2014 Sterility Tests USP 37-NF 32: 2014 BACTERIAL ENDOTOXINS TEST ISO 11135 Second Edition 2014 Sterilization of health care products — Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
Micro-Tech (Nanjing) Co., Ltd. Becky Li Manager of Quality Department No. 10 Gaoke Third Road National Hi-Tech, Industrial Development Zone Nanjing 210032 Jiangsu Province PRC
Re: K152802 Trade/Device Name: Grasping Forceps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCZ Dated: December 18, 2015 Received: December 21, 2015
Dear Becky Li.
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152802
Device Name
Grasping Forceps
Indications for Use (Describe)
Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue stylized "MT" on the left, followed by the text "MICRO-TECH" in blue. Below "MICRO-TECH" are two Chinese characters, also in blue.
Tab7
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 11/25/2015
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Manager of Quality Department Tel: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Product Name: Grasping Forceps Common Name: Grasping Forceps Requlatory Information Classification Name: endoscopic grasping/cutting instrument, non-powered Classification: 2 Product Code: OCZ Regulation Number: 876.1500 Review Panel: Gastroenterology/Urology
4. Indications for Use
Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
5. Device Description
The proposed device Grasping Forceps is a sterile, single-use device,
4
Image /page/4/Picture/1 description: The image contains a logo for Micro-Tech. The logo consists of a blue stylized letter "M" and "T" on the left side. To the right of the letters, the text "MICRO-TECH" is written in blue, with a line underneath it. Below the line, there are two Chinese characters.
designed to pass through a 2.8 mm or greater working channel of an endoscope.
The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.
The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.
6. Identification of Predicate Device
510(k) Number: K120084
Trade Name: The US Endoscopy Endoscopic Retrieval Device Regulation Name: Endoscope and accessories
7. 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 that the proposed device complies with the following standards:
ASTM F88/F88M-09, Standard Test Method For Seal Strength Of Flexible Barrier Materials.
ASTM F1929-12, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration.
ASTM F1140/F1140M-13, Standard Test Methods For Internal Pressurization Failure Resistance Of Unrestrained Packages.
ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices -Microbiological methods-Part 1: Determination of a population of
microorganisms on products
ASTM F1886/F1886M-09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
AAMI ANSI ST72:2011 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing.
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Image /page/5/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of a blue stylized letter "M" and "T" on the left, followed by the text "MICRO-TECH" in blue. Below the text is the Chinese translation of the company name.
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. ISO 10993-7:2008(R) 2012, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. USP 37 NF 32: 2014 Sterility Tests USP 37-NF 32: 2014 BACTERIAL ENDOTOXINS TEST ISO 11135 Second Edition 2014 Sterilization of health care products — Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
8. Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
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510K Summary
| Table 1 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| Item | Proposed Device | |||
| Grasping Forceps | Predicate Device (K120084) | |||
| The US Endoscopy Endoscopic Retrieval Device | Substantial Equivalence | |||
| Product Code | OCZ | OCZ | Same | |
| Regulation No. | 876.1500 | 876.1500 | Same | |
| Class | 2 | 2 | Same | |
| Supplied Sterile | Yes | Yes | Same | |
| Indications for Use | Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract. | The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures. | Similar | |
| Jaws open wide (mm) | 6.3mm, 8.1mm | 10mm | Similar | |
| Working Length | 1800mm, 2300mm | 2300mm | Similar | |
| Configuration | Jaws, Spring sheath, Finger ring | Jaws, Spring sheath, Finger ring | Same | |
| Single Use | Yes | Yes | Same | |
| Packaging | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Same | |
| Image: MICRO-TECH logo | 510K Summary | |||
| Item | Proposed Device | Predicate Device (K120084) | Substantial | |
| Equivalence | ||||
| Grasping Forceps | The US Endoscopy Endoscopic Retrieval | |||
| Device | ||||
| Shelf Life | Five years | Three years | Similar |
4/5
7
10.
as Substantialy Equivalent (SE) Conclusion
Based on the comparison and analysis from the nondinical tests, the proposed devices in affective, performances are
well as the pred