(211 days)
No
The description focuses on the mechanical function of the grasping forceps and does not mention any computational or algorithmic components.
No
The device is described as a tool for retrieving foreign objects or excised tissue, which is an interventional procedure rather than a therapeutic one. It does not actively treat a disease or condition.
No
This device is designed for retrieving foreign bodies and excised tissue, which is a therapeutic or interventional function, not a diagnostic one. It does not provide information about a medical condition.
No
The device description clearly outlines physical components like a thumb ring, spool, sliding handle, flexible shaft, and jaw assembly, indicating it is a hardware device.
Based on the provided information, the Rescue™ Pulmonary Grasping Forceps is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to retrieve foreign bodies and/or excised tissue from within the patient's body (upper airways and tracheobronchial tree) using an endoscope. This is an in vivo procedure, meaning it takes place within a living organism.
- Device Description: The description details a mechanical device designed for grasping and retrieving objects from within the body. It does not involve analyzing samples of bodily fluids, tissues, or other substances outside the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample analysis, or diagnostic results.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The Rescue™ Pulmonary Grasping Forceps is a surgical/interventional tool used in vivo.
N/A
Intended Use / Indications for Use
The Rescue™ Pulmonary Grasping Forceps are intended to retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.
Product codes
EOQ
Device Description
The Rescue™ Pulmonary Grasping Forceps is sterile, single-use devices. The Rescue™ Pulmonary Grasping Forceps can retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.
The Rescue™ Pulmonary Grasping Forceps is composed of thumb ring, spool and sliding handle at proximal end and the middle section of the Rescue™ Pulmonary Grasping Forceps is flexible shaft with a working length of 120 cm that connects with the distal end jaw assembly with an inner jaw opening of 4.5 mm. The Rescue™ Pulmonary Grasping Forceps is designed to pass through a 2.0 mm or greater working channel of a bronchoscope.
To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the pull wire which runs the length of the device and terminates with a connection to the jaws. Using Rescue™ Pulmonary Grasping Forceps the users can grasp excised tissue or foreign body by opening and then closing the jaws. The users can then retrieve the excised tissue or foreign body by pulling the Rescue™ Pulmonary Grasping Forceps with bronchoscope out of patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airways and tracheobronchial tree
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
The proposed Rescue™ Pulmonary Grasping Forceps was evaluated via bench-top testing, biocompatibility testing and sterilization testing.
The following bench-top testing was performed on the proposed Rescue™ Pulmonary Grasping Forceps:
- . Jaw opening width
- Effective working length .
- Maximum insertion portion outer diameter .
- . Flexibility - jaws open without seizing
- Flexibility jaw alignment .
- . Grasping reliability
- . Compatibility with bronchoscope
- Smooth edges .
- . Connect strength - clevis to coil joint
- . Connect strength - coil to handle joint
The proposed device passed all pre-defined testing requirements.
The Rescue™ Pulmonary Grasping Forceps was evaluated per the requirements of ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing. The device met the requirements of the performance standards and are considered biocompatible.
The Rescue™ Pulmonary Grasping Forceps was also evaluated per the sterilization requirements ISO 11135:2014 Sterilization of Health Care products - Ethylene Oxide - Requirements for the Development, Validation, and Routine Control of a Sterilization processes for Medical Devices and ISO 10993-7 Biological evaluation of medical devices - Part 7: ethvlene oxide sterilization residuals. The device met the requirements of the standards and is considered sterile.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Anrei Medical (Hangzhou) Co., Ltd % Jia Huang Senior Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K202987
Trade/Device Name: Rescue™ Pulmonary Grasping Forceps Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: September 28, 2020 Received: September 30, 2020
Dear Jia Huang:
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 device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Brandon L. Blakely, Ph.D. Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202987
Device Name Rescue™ Pulmonary Grasping Forceps
Indications for Use (Describe)
The Rescue™ Pulmonary Grasping Forceps are intended to retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.
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
1. Submitter:
Anrei Medical (Hangzhou) Co., Ltd No. 3, Ave. 8 Huangzhou Economic Development Area 310018 Hangzhou, P.R.China Telephone: (86) 571 8691 3333-8658 Fax: (86) 571 8760 3502
Huibing Yang Contact: Director, Regulatory Affairs
Date Prepared: April 29, 2021
2. Proposed Device:
Trade Name: | Rescue™ Pulmonary Grasping Forceps |
---|---|
Classification Name: | Bronchoscope (flexible or rigid) and accessories |
Regulation Number: | 874.4680 |
Product Code: | EOQ |
Classification: | Class II |
3. Predicate Device:
Trade Name: | Olympus FG Series of Grasping Forceps |
---|---|
510(k) Number: | K962533 |
Classification Name: | Bronchoscope (flexible or rigid) and accessories |
Regulation Number: | 874.4680 |
Product Code: | EOQ |
Classification: | Class II |
Reference Device: | EndoChoice Grasping Forceps |
Trade Name: | EndoChoice Grasping Forceps |
510(k) Number: | K101298 |
Classification Name: | Endoscopic Grasping/Cutting Instrument, Non-Powered |
Regulation Number: | 876.1500 |
Product Code: | OCZ |
Classification: | Class II |
4. Proposed Device Description:
The Rescue™ Pulmonary Grasping Forceps is sterile, single-use devices. The Rescue™ Pulmonary Grasping Forceps can retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.
The Rescue™ Pulmonary Grasping Forceps is composed of thumb ring, spool and sliding handle at proximal end and the middle section of the Rescue™ Pulmonary Grasping Forceps is flexible shaft with a working length of 120 cm that connects with the distal end jaw assembly with an inner jaw opening of 4.5 mm. The Rescue™ Pulmonary Grasping Forceps is designed to pass through a 2.0 mm or greater working channel of a bronchoscope.
4
To operate the device, the user slides the spool back and forth over the handle body to open and close the iaws. The spool simultaneously actuates the pull wire which runs the length of the device and terminates with a connection to the jaws. Using Rescue™ Pulmonary Grasping Forceps the users can grasp excised tissue or foreign body by opening and then closing the jaws. The users can then retrieve the excised tissue or foreign body by pulling the Rescue™ Pulmonary Grasping Forceps with bronchoscope out of patient.
5. Indications for Use:
The Rescue™ Pulmonary Grasping Forceps is indicated to be used to retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.
6. Technological Characteristics:
The proposed Rescue™ Pulmonary Grasping Forceps has identical intended use and similar technological characteristics as the predicate Olympus FG Series Grasping Forceps (K962533).
Both the proposed Rescue™ Pulmonary Grasping Forceps and the predicate Olympus FG Series Grasping Forceps (K962533) are designed to be composed of three major sections: proximal end, flexible shaft/catheter and distal end. The proposed Rescue™ Pulmonary Grasping Forceps and the predicate Olympus FG Series Grasping Forceps (K962533) share the similar technological characteristics as shown in table below.
| Technological
Characteristics | Proposed Rescue™
Pulmonary Grasping
Forceps | Predicate Olympus FG
Series Grasping Forceps
(K962533) |
|--------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------|
| Jaw Style | Rat Tooth | Rath Tooth, Alligator,
"W" Shape, Rubber Tipped
Cups |
| Inner Jaw Opening | 4.5 mm | 3-13 mm |
| Maximum Insertion Portion
Outer Diameter (mm) | 1.8 mm | 1.85-2.6 mm |
| Minimum Bronchoscope
Working Channel | 2.0 mm | 2.0 mm for FG-14P-1 with Rat
Tooth Grasping Jaws |
| Shaft Working Length | 120 cm | 105-190 cm |
The proposed Rescue™ Pulmonary Grasping Forceps is sterile, single use while the predicate Olympus FG Series Grasping Forceps (K962533) is reusable. The proposed Rescue™ Pulmonary Grasping Forceps is sterilized using ethylene oxide sterilization and the predicate Olympus FG Series Grasping Forceps (K962533) is reprocessed using method such as autoclave.
7. Performance Data:
The proposed Rescue™ Pulmonary Grasping Forceps was evaluated via bench-top testing, biocompatibility testing and sterilization testing.
The following bench-top testing was performed on the proposed Rescue™ Pulmonary Grasping Forceps:
- . Jaw opening width
- Effective working length .
- Maximum insertion portion outer diameter .
- . Flexibility - jaws open without seizing
5
- Flexibility jaw alignment .
- . Grasping reliability
- . Compatibility with bronchoscope
- Smooth edges .
- . Connect strength - clevis to coil joint
- . Connect strength - coil to handle joint
The proposed device passed all pre-defined testing requirements.
The Rescue™ Pulmonary Grasping Forceps was evaluated per the requirements of ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing. The device met the requirements of the performance standards and are considered biocompatible.
The Rescue™ Pulmonary Grasping Forceps was also evaluated per the sterilization requirements ISO 11135:2014 Sterilization of Health Care products - Ethylene Oxide - Requirements for the Development, Validation, and Routine Control of a Sterilization processes for Medical Devices and ISO 10993-7 Biological evaluation of medical devices - Part 7: ethvlene oxide sterilization residuals. The device met the requirements of the standards and is considered sterile.
8. Conclusion:
The proposed Rescue™ Pulmonary Grasping Forceps had passing results for the bench-top testing, biocompatibility and sterilization testing performed. The data provided by Anrei Medical (Hangzhou) Co., Ltd demonstrate that the proposed Rescue™ Pulmonary Grasping Forceps met the pre-defined design specifications and is suitable for the intended use. The data also demonstrate that the proposed Rescue™ Pulmonary Grasping Forceps is substantially equivalent to the currently marketed Olympus FG Series Grasping Forceps (K962533) and raises no new questions of safety or effectiveness.