(116 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a flexible tissue bag, with no mention of AI or ML technologies.
No
The device is described as a tissue containment system used to isolate tissue during surgical removal or manual morcellation, which is a containment and retrieval function, not a therapeutic one that treats or cures a disease or condition.
No
The device is described as a flexible tissue bag used to contain and isolate tissue during surgical removal and/or manual morcellation. Its function is to physically manage tissue, not to diagnose conditions or diseases.
No
The device description clearly describes a physical tissue bag with a tether and guard, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation." This describes a surgical tool used during a procedure to manage tissue.
- Device Description: The description details a "flexible tissue bag" used to "contain and isolate specimens for surgical removal and/or manual morcellation." This further reinforces its role as a surgical accessory for handling tissue.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis or provide diagnostic information. It is purely a containment and isolation tool for tissue during surgery.
The device's function is entirely focused on the physical handling and containment of tissue during a surgical procedure, not on analyzing the tissue to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
Contraindications:
The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Containment System 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Applied Medical Tissue Containment System is a flexible tissue bag that includes an attached tether and guard accessory. The subject system is provided sterile. The Tissue Containment System is used to contain and isolate specimens for surgical removal and/or manual morcellation. After the device is fully inserted into the abdominal or pelvic cavity, the mouth of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether is used to maneuver the ring to the surface of the extraction site. If the specimen requires manual morcellation, the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site. The guard is placed in the bag opening prior to manual morcellation, providing a robust barrier between the bag and sharp instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal or pelvic cavity
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)
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the Applied Medical Tissue Containment System was conducted in accordance with the FDA G95-1 Blue Book Memo, the FDA Draft Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing''', and the International Standard ISO 10993-1. The subject device is a device that contacts tissue for a duration of less than 24 hours and the following tests were considered:
- Cytotoxicity
- Irritation
- Sensitization
All materials were found to be biocompatible.
Mechanical Testing
Side-by-side bench top testing was performed with the subject and predicate devices to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of the specimen containment and retrieval features, as well as its use during morcellation. Both subject and predicate devices were evaluated for:
- Bag seam integrity
- Tether break force
- Puncture resistance
Additional testing was performed on the subject device to evaluate the device functionality:
- Dye penetration
- Viral penetration
- Bubble leak
- Simulated use
Conclusions:
Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent to the predicates Applied Medical Specimen Retrieval System and Cook LapSac Tissue Entrapment Pouch, and that the subject device performs comparably to the current marketed device for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Applied Medical Specimen Retrieval System 510(k)#: K060051, Cook LapSac Tissue Entrapment Pouch 510(k)#: K910914
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Applied Medical Resources Corporation Ms. Aeree Lee Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K142427
Trade/Device Name: Applied Medical Tissue Containment System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 21, 2014 Received: November 24, 2014
Dear Ms. Lee:
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
1
device-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/Resourcesfor You/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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142427
Device Name
Applied Medical Tissue Containment System
Indications for Use (Describe)
The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
Contraindications:
The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Containment System 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(K) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Contact Person: | Aeree Lee
Regulatory Affairs Specialist
Applied Medical Resources
aelee@appliedmedical.com
Tel: (949) 713-8272
Fax: (949) 713-8205 | |
| Date of Preparation: | August 28, 2014 | |
| Trade Name: | Applied Medical Tissue Containment System | |
| Common Name: | Tissue Bag | |
| Classification: | Accessory to Endoscope, Class II
Product Code: GCJ | Regulation: 21 CFR 876.1500 |
| Predicate Device: | Applied Medical Specimen Retrieval System
510(k)#: K060051
Product Code: GCJ | Regulation: 21 CFR 876.1500 |
| | Cook LapSac Tissue Entrapment Pouch
510(k)#: K910914
Product Code: KGY | Regulation: 21 CFR 878.4100 |
| Device Description: | The Applied Medical Tissue Containment System is a flexible
tissue bag that includes an attached tether and guard accessory.
The subject system is provided sterile.
The Tissue Containment System is used to contain and isolate
specimens for surgical removal and/or manual morcellation.
After the device is fully inserted into the abdominal or pelvic
cavity, the mouth of the bag returns to its original, circular shape,
facilitating placement of the specimen in the bag. When the
specimen is ready for removal and/or manual morcellation, the
tether is used to maneuver the ring to the surface of the | |
| | If the specimen requires manual morcellation, the ring may be
repeatedly flipped to shorten the bag and consequently bring the
specimen closer to the extraction site. The guard is placed in the
bag opening prior to manual morcellation, providing a robust
barrier between the bag and sharp instruments. | |
| Intended Use: | The Applied Medical Tissue Containment System is indicated to
contain and isolate tissue during, or prior to, surgical removal
and/or extracorporeal manual morcellation. | |
| | The Tissue Containment System is contraindicated for laparoscopic
power morcellation during gynecologic procedures. | |
| | The Tissue Containment System 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. | |
4
extraction site.
Comparison of Technological Characteristics with the Predicate Device:
The subject and predicate devices are both tissue bags intended to retrieve and contain specimens during manual morcellation. Both devices are wholly inserted into the abdominal or pelvic cavity prior to specimen placement in the bag. If the specimen requires morcellation, both bags are brought up to the extraction site prior to morcellation.
The following technological differences exist between the subject and predicate devices:
- Mechanism of the bag opening
- o Use of different materials
- 0 Addition of a guard in subject device
Discussion of Performance Testing:
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the Applied Medical Tissue Containment System was conducted in accordance with the FDA G95-1 Blue Book Memo, the FDA Draft Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing''', and the International Standard ISO 10993-1. The subject
5
device is a device that contacts tissue for a duration of less than 24 hours and the following tests were considered:
- Cytotoxicity
- Irritation ●
- o Sensitization
All materials were found to be biocompatible.
Mechanical Testing
Side-by-side bench top testing was performed with the subject and predicate devices to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of the specimen containment and retrieval features, as well as its use during morcellation. Both subject and predicate devices were evaluated for:
- Bag seam integrity
- o Tether break force
- o Puncture resistance
Additional testing was performed on the subject device to evaluate the device functionality:
- Dye penetration
- Viral penetration
- Bubble leak ●
- o Simulated use
Conclusions:
Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent to the predicates Applied Medical Specimen Retrieval System and Cook LapSac Tissue Entrapment Pouch, and that the subject device performs comparably to the current marketed device for the same intended use.