(90 days)
No
The device description and performance studies focus on mechanical functionality and material properties, with no mention of AI or ML.
No
It is a retrieval system for tissue, organs, and calculi during laparoscopic surgical procedures, not a device used for treating disease or repairing injury.
No
The device is described as a specimen retrieval system used for collection of tissue, organs, and calculi during laparoscopic surgical procedures. Its function is to enclose tissue specimens for retrieval, not to analyze them or provide information for diagnosis.
No
The device description clearly outlines physical components (handle, tube, string, nylon bag) and describes a mechanical function (deploying and retracting a bag). There is no mention of software as a component or function.
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 "collection of tissue, organs, and calculi during laparoscopic surgical procedures." This describes a device used during a surgical procedure to physically retrieve specimens from the body.
- Device Description: The description details a physical system with a handle, tube, string, and bag for enclosing and retrieving specimens. This is a mechanical device for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples in vitro (outside the body) to provide diagnostic information. IVDs typically involve reagents, assays, or other methods for analyzing biological samples to detect diseases, conditions, or other health states.
The device is clearly intended for surgical specimen retrieval, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.
Product codes
GCJ
Device Description
The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures. The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.
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
Operating Room
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
Bench testing was completed to ensure the device meets its performance specifications and functions effectively. Device characteristics tested included device pressure leak rate, bag leakage and volume, bag puncture resistance, bag burst resistance, retraction and deployment functionality, and cinch string strength. All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively.
Key Metrics
Not Found
Predicate Device(s)
Anchor Laparoscopic Tissue Retrieval System [K091930]
Reference Device(s)
Applied Medical Specimen Retrieval System (K100959)
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
DeRoyal Industries. Inc. Ms. Sarah Bennett Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
Re: K171475
Trade/Device Name: DeRoyal Laprador Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 11, 2017 Received: August 14, 2017
Dear Ms. Bennett:
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 Actinclude 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 (reporting of medical device-
Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be connected.
1
related 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,
Jennifer R. Stevenson -S3
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)
K171475
Device Name
DeRoyal Laprador Specimen Retrieval System
Indications for Use (Describe)
The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.
Contraindications
The DeRoyal Laprador Specimen Retrieval System is contraindicated for use when, in the judgment of the licensed clinician, use of such a device would not be in the best interest of the patient.
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 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."
page 4-2
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Image /page/3/Picture/2 description: The image shows the logo for DeRoyal. The logo features a stylized blue swoosh above the text "DeRoyal" in a matching blue color. A registered trademark symbol is located to the right of the word "Royal".
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
DeRoyal Industries, Inc. Traditional 510(k) Submission – DeRoyal Laprador Specimen Retrieval System May 18, 2017
510(k) Summary
| Date prepared: | May 18, 2017 |
|---|---|
| 510(k) Owner: | DeRoyal Industries, Inc. |
| 200 DeBusk Lane | |
| Powell, TN 37849 | |
| Owner/Operator #1044833 | |
| 510(k) Contact: | Sarah Bennett |
| Regulatory Affairs Specialist | |
| P: 865-362-6112 | |
| F: 865-362-3741 | |
| sabennett@deroyal.com | |
| Contract Manufacturer: | DeRoyal Intercontinental, S.R.L. |
| Km 7, Autopista Joaquin Balaguer | |
| Pisano Free Zone, Building 49 | |
| Santiago Santiago, DO | |
| FDA Establishment #3004605321 | |
| Trade Name: | DeRoyal Laprador Specimen |
| Retrieval System | |
| Common Name: | Specimen Retrieval Bag |
| Classification Name: | Laparoscope, General & |
| Plastic Surgery (21 CFR 876.1500) | |
| Regulatory Class: | Class II |
| Device Product Code: | GCJ |
| Classification Panel: | General & Plastic Surgery |
| Predicate Devices: | Anchor Laparoscopic Tissue |
| Retrieval System [K091930] |
Device Description
The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures.
4
Image /page/4/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the company name "DeRoyal" in blue lettering. A registered trademark symbol is located to the right of the word "Royal".
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
K171475
The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.
Intended Use
The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection and extraction of tissue, organs, and calculi during laparoscopic surgical procedures.
Summary of Technological Characteristics
The intended use and design are identical to the predicate devices. The proposed device is sterilized by ethylene oxide and utilizes a rip-stop nylon material for the bag construction. This sterilization method and bag material are identical to the method and bag material utilized by the Anchor Tissue Retrieval System (K091930). The mechanisms to load the tissue bag into the introducer shaft and separate the bag from the deployment shaft are different; however, bench test results demonstrate these differences do not raise new issues of safety and effectiveness. The proposed device is substantially equivalent as it poses no new changes that could impact safety and effectiveness.
| Characteristic | DeRoyal Laprador
Specimen Retrieval System | Predicate
Device
Anchor
K091930 |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Intended for collection and
extraction of tissue, organs,
and calculi during
laparoscopic surgical
procedures. | Same |
| Where Used | Operating Room | Same |
| Prescription
Only | Yes | Same |
| Design | Specimen bag and a delivery
system consisting of an
introducer shaft and
deployment handle | Same |
| Materials | Nylon bag and cinch string,
polyester stitching, ABS
handles and shaft, and
stainless steel rod and spring | Nylon bag,
plastic
handles
tubes and
rods |
| Mechanism to
load tissue bag
into introducer
shaft | Pull Tail hook loop | Hook and
spring
mechanism
at distal end. |
| Mechanism to | Rotating hook | Push button |
5
Image /page/5/Picture/2 description: The image features the logo for "DeRoyal". The logo consists of a stylized blue swoosh above the text "DeRoyal", also in blue. A registered trademark symbol is located to the right of the word "Royal".
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
| separate bag | ||
|---|---|---|
| from deployment | ||
| shaft | ||
| Performance | There are no FDA | Same |
| performance standards for this | ||
| device. Therefore, bench | ||
| testing was performed. | ||
| Sterilization | Ethylene Oxide per ISO | Same |
| 11135-1: 2014 | ||
| Biocompatibility | According to ISO 10993-1: | Same |
| 2009 |
Summary of Performance Tests
Bench testing was completed to ensure the device meets its performance specifications and functions effectively. Device characteristics tested included device pressure leak rate, bag leakage and volume, bag puncture resistance, bag burst resistance, retraction and deployment functionality, and cinch string strength. All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively.
Conclusion
The results of the performance and comparative testing demonstrate the DeRoyal Laprador Specimen Retrieval System is substantially equivalent to the predicate devices, the Anchor Tissue Retrieval System cleared under K091930.