(23 days)
Not Found
No
The description focuses on the mechanical function and materials of a specimen retrieval bag, with no mention of AI or ML capabilities.
No.
The device is used for the removal of tissue specimens and does not directly provide therapy or treatment.
No
The device is a specimen retrieval bag used for removing tissues from the body, which is a surgical tool, not a diagnostic one.
No
The device description clearly outlines physical components (cylindrical tube, nylon bag, handle) and performance testing related to physical properties (forces, burst pressure, leak rate), indicating 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 for the removal of tissue specimens from the body cavity. This is a surgical or procedural function, not a diagnostic test performed in vitro (outside the body) on a specimen.
- Device Description: The device is a physical bag designed to encapsulate and contain specimens for removal. It does not involve any reagents, assays, or analysis of the specimen itself for diagnostic purposes.
- Lack of Diagnostic Information: The description does not mention any diagnostic claims, analysis of biological samples, or the generation of diagnostic results.
- Performance Studies: The performance studies focus on the physical characteristics and functionality of the bag (leak rate, forces, burst pressure, usability), which are relevant to its function as a retrieval device, not a diagnostic one.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely for the physical retrieval of the specimen.
N/A
Intended Use / Indications for Use
The specimen retrieval bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.
Product codes
GCJ
Device Description
The ReliaCatch™ 10mm Specimen Retrieval Bag and ReliaCatch™ 12mm Specimen Retrieval Bag consist of a long cylindrical tube and a rip-stop nylon bag that encapsulates and contains specimens for removal from the body cavity. The device contains a handle used to retract and deploy the bag. The specimen bag is designed for introduction and use through all appropriately sized trocar sleeves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance testing included:
- Leak Rate Evaluation
- Trocar Insertion Force
- Trocar Removal Force
- Pouch Deployment Force
- Pouch Retraction Force
- Pouch Cinch Force
- Pouch Burst Pressure
- Human Factors/Usability
Objective acceptance criteria were defined for each test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Covidien Ms. Kate Brown Associate, Regulatory Affairs 60 Middleton Ave. North Haven, Connecticut 06473
Re: K163102
Trade/Device Name: ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 2, 2016 Received: November 7, 2016
Dear Ms. Brown:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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, Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name ReliaCatch™M Specimen Retrieval Bag
Indications for Use (Describe)
The specimen retrieval bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.
| 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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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
"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."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image shows the word "Medtronic" in a bold, blue font. The letters are closely spaced and appear to be sans-serif. The logo is simple and modern, with a dot above the "i".
510(k) Summary
This 510(k) summary of data used to demonstrate substantial equivalence is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98
| NAME: | Covidien |
|---|---|
| ADDRESS: | 60 Middletown Avenue |
| North Haven, Connecticut 06473 USA | |
| CONTACT PERSON: | Kate Brown |
| Associate, Regulatory Affairs | |
| PHONE NUMBER: | (203) 492-8350 |
| FAX NUMBER: | (203) 492-5029 |
| DATE PREPARED: | 11/02/2016 |
| TRADE/PROPRIETARY NAME: | ReliaCatch™ 10mm Specimen Retrieval Bag / |
| ReliaCatch™ 12mm Specimen Retrieval Bag | |
| COMMON/USUAL NAME: | Specimen Retrieval Device |
| CLASSIFICATION NAME: | Endoscope and Accessories per 21 CFR § |
| 876.1500 | |
| PRODUCT CODE: | GCJ |
| CLASSIFICATION PANEL NAME: | General and Plastic Surgery |
| FDA PANEL NUMBER: | 79 |
| DEVICE CLASS: | Pursuant to 21 CFR § 876.1500 an endoscope and |
| accessories is a Class II device | |
| PREDICATE DEVICE(S): | EndoCatch™ Gold previously cleared as Auto |
| Suture™ disposable endoscopic specimen pouch | |
| [K922123] | |
| DEVICE DESCRIPTION: | The ReliaCatch™ 10mm Specimen Retrieval Bag |
| and ReliaCatch™ 12mm Specimen Retrieval Bag | |
| consist of a long cylindrical tube and a rip-stop | |
| nylon bag that encapsulates and contains | |
| specimens for removal from the body cavity. The | |
| device contains a handle used to retract and deploy | |
| the bag. The specimen bag is designed for | |
| introduction and use through all appropriately sized | |
| trocar sleeves. |
4
Medtronic
INTENDED USE:
The specimen retrieval bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowl and other tissue structures.
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED AND PREDICATE DEVICE(S)
The predicate device EndoCatch™ is packaged with the bag inside of the tube. Upon opening the package, the device is inserted into the trocar where the baq is deployed and the specimen retrieved. In the new design, the ReliaCatch™ device is packaged with the bag outside of the tube. Upon opening the package, the bag must initially be retracted into the tube prior to inserting into the trocar, and then deployed, and specimen retrieved. Additionally, the subject device will utilize a suture loop to cinch the bag once the specimen is retrieved, where the predicate utilized a ring. The predicate design consisted of a bag attached to a stainless steel spring. Once specimen is retrieved, the bag is cinched by pulling the gold ring and detaching the bag from the metal spring. The metal spring would then be retracted into the tube and the string cut, leaving the bag in the body cavity while the EndoCatch™ device is removed from the trocar. The subject device consists of a bag on "forks" which allows for the complete removal of the forks from the bag prior to cinching the bag and removing the specimen from the body cavity. Lastly, the suture material was changed to better perform in conjunction with the new rip-stop nylon bag material.
MATERIALS:
All components of the ReliaCatch™ specimen retrieval bag are comprised of materials which are in accordance with ISO 10993-1.
5
Medtronic
PERFORMANCE DATA:
Summary of testing includes description of test methods, sample size, acceptance criteria, and pass/fail results. Objective acceptance criteria were defined for each test. Performance testing included:
- Leak Rate Evaluation ●
- Trocar Insertion Force ●
- Trocar Removal Force ●
- Pouch Deployment Force ●
- Pouch Retraction Force
- . Pouch Cinch Force
- Pouch Burst Pressure
- Human Factors/Usability
CONCLUSION:
The results of the performance and comparative testing described above demonstrate that the ReliaCatch™ specimen retrieval bag is substantially equivalent to the predicate device, EndoCatch™ Gold specimen pouch cleared under [K922123].