(267 days)
Not Found
No
The summary describes a mechanical tissue retrieval system with no mention of AI or ML components or functionalities.
No
The device is a retrieval pouch used for the removal of organs or tissues, not for treating a disease or condition.
No
The device is a sterile, disposable pouch used for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy. It is an instrument for surgical removal, not for diagnosis.
No
The device description clearly outlines physical components made of rip stop nylon, polyurethane laminate, and stainless steel, indicating it is a hardware device.
Based on the provided information, the Anchor™ Tissue Retrieval System™ by CONMED is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy." This describes a surgical procedure for removing tissue from the body, not for testing or analyzing samples in vitro (outside the body).
- Device Description: The description details a physical pouch and introducer designed for containing and removing tissue. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue for diagnostic purposes)
- Measurement of analytes
- Diagnostic claims
The device is clearly intended for a surgical procedure to remove tissue, not for diagnostic testing of that tissue.
N/A
Intended Use / Indications for Use
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy.
Product codes
GCJ
Device Description
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile, disposable, retrieval pouch for use with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy. The Anchor™ Tissue Retrieval System™ by CONMED consists of a rip stop nylon with polyurethane laminate pouch and two stainless steel arms attached to internal pusher rod, which is connected to a handle at the end distal to the patient. Around the internal pusher rod is the introducer with handle. The introducer handle incorporates a spring-loaded button and a stop mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch with polyurethane laminate.
If the surgeon deems it appropriate, the Anchor™ Tissue Retrieval System™ by CONMED can be redeployed in the same single patient procedure.
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
Design verification activities demonstrate the device meets design specifications. These activities include verification of bag volume, drawstring length, puncture resistance, multiple deployments, insertion/removal force, and bag burst pressure. Design validation activities consisted of simulated use in a cadaver model. Users performance including insertion, multiple assessed device deplovments. device/specimen removal, clarity of instructions for use and overall reliability and quality of the device. The results of design validation testing were acceptable.
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/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 11, 2018
ConMed Corporation Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, NY 13502
Re: K173822
Trade/Device Name: Anchor™ Tissue Retrieval System™ by CONMED Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: August 9, 2018 Received: August 10, 2018
Dear Lisa Anderson:
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 mav, 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 avare 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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -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
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Indications for Use
510(k) Number (if known) K173822
Device Name
AnchorTM Tissue Retrieval System™ by CONMED
Indications for Use (Describe)
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy.
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 of Safety and Effectiveness
Anchor™ Tissue Retrieval System™ by CONMED
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K173822 as of September 11, 2018.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Manager, Regulatory Affairs T: (941) 713-2035 F: (315) 624-3225
C. Device Name
Proprietary Name: Anchor™ Tissue Retrieval System™ by CONMED Common Name: Specimen Retrieval Baq Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Product Code: GCJ (laparoscope, general & plastic surgery) Device Class: .
D. Predicate Device
| Primary Device Name: | Anchor Tissue Retrieval System |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K172940 |
This predicate has not been the subject to a design-related recall.
E. Device Description
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile, disposable, retrieval pouch for use with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy. The Anchor™ Tissue Retrieval System™ by CONMED consists of a rip stop nylon with polyurethane laminate pouch and two stainless steel arms attached to internal pusher rod, which is connected to a handle at the end distal to the patient. Around the internal pusher rod is the introducer with handle. The introducer handle incorporates a spring-loaded button and a stop
4
mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch with polyurethane laminate.
If the surgeon deems it appropriate, the Anchor™ Tissue Retrieval System™ by CONMED can be redeployed in the same single patient procedure.
F. Indications for Use
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue laparoscopic hysterectomy.
In comparison with the predicate device, the subject device is designed for the same intended use of encapture and removal of an organ and tissue from the body cavity. The devices differ in the mode of insertion and surgical procedure. The predicate is intended to be inserted into the body cavity via a laparoscopic access port and indicated for use during laparoscopic surgery. The subject device is intended to be inserted through the vaginal canal and indicated for use during laparoscopic hysterectomy.
G. Technological Characteristics
The Anchor™ Tissue Retrieval System™ by CONMED has similar technological characteristics as the predicate device in that the Anchor™ Tissue Retrieval System™ by CONMED has the same design, same deployment mechanism, and utilizes the same materials including the rip stop nylon with polyurethane laminate, introducer components, and external introducer as the predicate. As with the predicate, the Anchor™ Tissue Retrieval System™ by CONMED continues to function as a single patient procedure pouch with a dedicated introducer for the encapture and removal of the organ or tissue during laparoscopic surgery. The differences in the subject device from the predicate device is that the subject device has larger dimensions than the predicate device, the shape of the introducer is different, the stainless steel used is different and the subject device will be inserted into the patient directly through a natural body orifice.
| Characteristic | Anchor™ Tissue Retrieval System™ by
CONMED | Predicate Device
K172940 |
|-------------------------|----------------------------------------------------------------------------------------------|-----------------------------|
| Where Used | Operating room | Same |
| Prescription Only | Yes | Same |
| Design | Specimen bag and a delivery system
consisting of an introducer shaft deployment
handle | Same |
| Materials | Nylon, stainless steel, polycarbonate | Same |
| Introducer Shape | Oval | Round |
| Toggle material | 420 Stainless Steel | 302 Stainless Steel |
| Mechanism to deploy bag | Automatic with compression of pusher rod | Same |
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| Characteristic | Anchor™ Tissue Retrieval System™ by CONMED | Predicate Device K172940 |
|---|---|---|
| Mechanism to redeploy bag | Automatic with compression of pusher rod | Same |
| Mechanism to separate bag from introducer | Push button | Same |
| Bag volume | 6000mL | 125-1800mL |
The differences between the predicate device and the proposed device do not raise any different risks of safety or effectiveness.
H. Summary of Performance Testing
Design verification activities demonstrate the device meets design specifications. These activities include verification of bag volume, drawstring length, puncture resistance, multiple deployments, insertion/removal force, and bag burst pressure. Design validation activities consisted of simulated use in a cadaver model. Users performance including insertion, multiple assessed device deplovments. device/specimen removal, clarity of instructions for use and overall reliability and quality of the device. The results of design validation testing were acceptable.
Conclusion l.
Supporting information per this premarket submission confirms that the Anchor™ Tissue Retrieval System™ by CONMED is as safe and effective for its intended use as the predicate Anchor Tissue Retrieval System™.