(85 days)
No
The 510(k) summary describes a simple, single-use mechanical device (impervious bags) for tissue retrieval during surgery. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is described as a receptacle for the collection and extraction of tissue during surgical procedures, which is a tool used in a therapeutic procedure but does not itself provide therapy.
No
Explanation: The device is described as a "receptacle for the collection and extraction of tissue during laparoscopic surgical procedures," indicating it is an surgical tool for tissue removal, not a device for diagnosis.
No
The device description clearly states it is a "Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures," indicating a physical, hardware-based device (impervious bags).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "collection and extraction of tissue during laparoscopic surgical procedures." This is a surgical tool used in vivo (within the body) to handle tissue removed from the body.
- Device Description: The description reinforces this, stating it's a "receptacle for the collection and extraction of tissue during laparoscopic surgical procedures."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue in a lab setting.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The family of impervious bags for endoscopic retrieval of tissue are single-use The family of importantes for the collection and extraction and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags for the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).
Product codes
GCJ
Device Description
Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the Nubert, Albert and Hubert Impervious Bags is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Vernon-Carus Limited
Penwortham Mills
Preston, Lancashire PR1 9SN
United Kingdom |
|----------------------|-------------------------------------------------------------------------------------------|
| | Mr. Alan Davies
Group Regulatory Affairs Manager |
| | Contact Person: |
| Preparation Date: | 14 November 2003 |
| Device Trade Name: | Nubert, Albert and Hubert Impervious Bags for
the Endoscopic Retrieval of Tissue |
| Common Name: | Laparoscopic Specimen Retrieval Bag |
| Classification Name: | Laparoscopic, General and Plastic Surgery
21 CFR 876.1500 |
Predicate Devices:
Device Description:
Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures.
1
K035842 2/2
Intended Use of the Device:
The Nubert, Albert and Hubert impervious bags for endoscopic retrieval of tissue arc single-use disposable devices used as receptacles for the collection and extraction of tissue during laparoscopic surgical procedures. There are three sizes of impervious bags for the endoscopic retrieval of tissuc: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).
Substantial Equivalence to Predicate Devices:
The Nubert, Albert and Hubert Impervious Bags for the Endoscopic Retrieval of Tissue are substantially equivalent in design and materials to the listed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized depiction of an eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4. 2004
Vernon-Carus Limited c/o Mr. C. Robert Payne, Jr., P.E. CRP Enterprises P.O. Box 2608 Morgan Hill, California 95038
Re: K033842 Trade/Device Name: Nubert, Albert and Hubcrt Impervious Bags for the Endoscopic Retrieval of Tissue Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 14, 2003 Received: December 10, 2003
Dear Mr. Payne:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booten or (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use nated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered provided in accordance with the provisions of the Federal Food, Drug, ue vices that have been require approval of a premarket approval application (PMA). and Cosmotion For (110) that the device, subject to the general controls provisions of the Act. The I ou may, disrettle, mains of the Act include requirements for annual registration, listing of general controlly provider ing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it rr your device is elassinod (tional controls. Existing major regulations affecting your device can may be subject to Sach assisted Regulations, Title 21, Parts 800 to 898. In addition, FDA may oc round in the Outsernents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri which that your device complies with other requirements of the Act that I DA has Inade a determinations administered by other Federal agencies. You must of any i cutar statures and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crith in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordiner me quality by court of Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. C. Robert Payne, Jr., P.E.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maxing of substantial equivalence of your device to a legally premarket notincation: "The PDF mailing sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for Joan as 1) 594-4659. Also, please note the regulation entitled, Connact the Office of Comptimation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Ericlosure
4
INDICATIONS FOR USE
510(k) Number: K033842
Nubert, Albert and Hubert Impervious Bags for the Endoscopic Device Name: Retrieval of Tissue
Indications for Use:
The family of impervious bags for endoscopic retrieval of tissue are single-use The family of importantes for the collection and extraction and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags for the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line -- Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
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510(k) Number K033842