(86 days)
No
The device description and performance studies focus on the physical properties and functionality of a surgical pouch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for the containment and removal of tissue during surgical procedures, not for treating a disease or condition.
No
This device is designed for the containment and removal of tissue during surgical procedures, not for identifying or characterizing diseases or conditions.
No
The device description clearly outlines physical components (polymer film bag, flip ring, guard) and the performance studies focus on the physical properties and integrity of these components (impermeability, leak testing, strength testing, etc.). There is no mention of software as part of the device itself.
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 and containment of tissue during surgical procedures. This is a surgical tool used in vivo (within the body) and ex vivo (outside the body for manual morcellation).
- Device Description: The description details a physical pouch designed to hold tissue during surgery. It does not describe any components or processes related to analyzing biological samples in vitro (outside the body) for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to test, analyze, or provide information about a patient's health status based on biological samples.
- Performance Studies: The performance studies focus on the physical properties and functionality of the pouch (impermeability, strength, resistance, etc.) and its biocompatibility, not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.
Product codes
GCJ
Device Description
The Tissue Removal Pouch includes a polymer film bag, a flip ring packaged in two halves, and a guard. It is provided sterile and is for single patient use.
The bag has a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation and removal from the patient. The bag opening is then exteriorized. The two halves of the flip ring are attached to each other and to the bag opening.
The bag is rolled around the flip ring by inverting the flip ring in order to draw the resected tissue toward the port site. The resected tissue is then removed en bloc (for smaller specimens) or by extracorporeal manual morcellation (for larger specimens). The guard may be used to protect the bag during manual morcellation. The bag is removed following the removal of sufficient tissue to be pulled out through the port site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal space
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
Non-Clinical Testing:
- Film Impermeability Testing: ● Verifies film impermeability.
- . Bubble Leak Testing: Demonstrates that the bag of the Tissue Removal Pouch is leak free.
- . Weld Strenath Testing: Demonstrates adequate weld strength.
- . Puncture Resistance Testing: Demonstrates adequate resistance to puncture.
- . Burst Testina: Demonstrates adequate burst strength.
- . Opening Ring Pull Testing: Demonstrates adequate pull strength.
- . Guard Cut Resistance Testing: Demonstrates adequate resistance to cutting.
- . Simulated Use Testing Demonstrates that the Tissue Removal Pouch performs as intended.
- . Biocompatibility Testing Demonstrates that the device is biocompatible.
- Dye Penetration Testing . Demonstrates that the Tissue Removal Pouch is leak free.
- . Viral Penetration Testing Demonstrates that the Tissue Removal Pouch is and adeguate barrier to cellular migration.
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 is the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Boehringer Laboratories, LLC Mr. Christopher Radl Engineering and Product Development Manager 300 Thoms Drive Phoenixville, Pennsylvania 19460
Re: K150781
Trade/Device Name: Tissue Removal Pouch Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 10, 2015 Received: June 10, 2015
Dear Mr. Radl:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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 yours.
Jennifer R. Stevenson -S
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
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Indications for Use
510(k) Number (if known)
Device Name
Tissue Removal Pouch
Indications for Use (Describe)
The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.
Contraindications:
The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Removal Pouch is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to 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)
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510(k) Summary
Prepared: June 9, 2015
APPLICANT INFORMATION:
Name: Boehringer Laboratories. LLC Address: 300 Thoms Drive Phoenixville, PA 19460 Phone: 610-278-0900 Fax: 610-278-0907 Contact: Christopher Radl; Engineering, Product Development Manager
Signature: Date:
d June 9, 2015
TRADE NAME:
Tissue Removal Pouch
COMMON NAME:
Laparoscopic Retrieval Device
Device Classification:
Accessory to Endoscope, Class II Product Code: GCJ Regulation: 876.1500 Endoscope and Accessories Classification Panel: General & Plastic Surgery
PREDICATE DEVICES:
| Primary Predicate: | Applied Medical Tissue Containment System | K142427 |
|---|---|---|
| Additional Predicate: | Applied Medical Specimen Retrieval System | K060051 |
Device Description:
The Tissue Removal Pouch includes a polymer film bag, a flip ring packaged in two halves, and a guard. It is provided sterile and is for single patient use.
The bag has a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation and removal from the patient. The bag opening is then exteriorized. The two halves of the flip ring are attached to each other and to the bag opening.
The bag is rolled around the flip ring by inverting the flip ring in order to draw the resected tissue toward the port site. The resected tissue is then removed en bloc (for smaller specimens) or by extracorporeal manual morcellation (for larger specimens). The guard may be used to protect the bag during manual morcellation. The bag is removed following the removal of sufficient tissue to be pulled out through the port site.
INTENDED USE:
The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.
The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures.
4
The Tissue Removal Pouch is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the physician, use of such a device would be contrary to the best interest of the patient.
Comparison Summary:
The Tissue Removal Pouch and predicate devices are intended for tissue containment and removal during laparoscopic surgery. All devices are single use, and sterile, with a biocompatible polymer film bag portion, that has a single opening incorporating an opening mechanism. Furthermore, the bag portion of all devices is inserted into the peritoneal cavity of the patient, loaded with a specimen, and exteriorization. All devices provide some mechanism to assist in the removal of the bag and the specimen.
The following aspects involve slight differences between the Tissue Removal Pouch and one or both of the predicate devices:
- Mechanism of bag insertion
- . Mechanism of bag exteriorization
- Morcellation protection
- Bag volume
Non-Clinical Testing:
The following non-clinical tests have been included with this submission:
- Film Impermeability Testing: ● Verifies film impermeability.
- . Bubble Leak Testing: Demonstrates that the bag of the Tissue Removal Pouch is leak free.
- . Weld Strenath Testing: Demonstrates adequate weld strength.
- . Puncture Resistance Testing: Demonstrates adequate resistance to puncture.
- . Burst Testina: Demonstrates adequate burst strength.
- . Opening Ring Pull Testing: Demonstrates adequate pull strength.
- . Guard Cut Resistance Testing: Demonstrates adequate resistance to cutting.
- . Simulated Use Testing Demonstrates that the Tissue Removal Pouch performs as intended.
- . Biocompatibility Testing Demonstrates that the device is biocompatible.
- Dye Penetration Testing . Demonstrates that the Tissue Removal Pouch is leak free.
- . Viral Penetration Testing Demonstrates that the Tissue Removal Pouch is and adeguate barrier to cellular migration.
Conclusions:
As evidenced by the provided information, the Tissue Removal Pouch is as safe and effective as, and performs as well as, or better than, the legally marketed predicate devices.