(15 days)
No
The device description and performance studies focus on mechanical functionality and material properties, with no mention of AI/ML terms or data processing capabilities.
No
The device is described as a receptacle for collecting and extracting tissues, organs, and calculi during surgical procedures, not for treating or diagnosing a disease or condition.
No
Explanation: The device is described as a "receptacle for the collection and extraction of tissue, organs and calculi" during surgical procedures. Its function is to hold and retrieve specimens, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description explicitly states it is a disposable receptacle constructed of various polymers and stainless steel, clearly indicating it is a hardware device.
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 and extraction of tissue, organs, and calculi during surgical procedures. This is a surgical tool used in vivo (within the body) to handle specimens, not to perform diagnostic tests in vitro (outside the body) on those specimens.
- Device Description: The description details a physical receptacle and introducer for surgical use, not a device designed to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The device's function is purely mechanical for specimen handling.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Applied Medical specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
Product codes
GCJ
Device Description
The Applied medical specimen Retrieval System is a disposable receptacle used to collect and extract tissue, organs and calculi during laparoscopic procedures. It consists of a flexible polymer bag and an introducer structure that fits through a trocar port. Extracorporeal activation of the introducer handle ejects the flexible bag which automatically opens in preparation for receipt of the specimen. The device is constructed of various polymers and stainless steel. It is packaged in a Tyvek/Mylar peel pouch and a product shelf pack. The shelf pack will be sterilized using gamma irradiation per AAMI/ISO guidelines. Sterility Assurance Level will be 10°.
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)
Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K060051. These tests focused on functionality, robustness and bag strength. Test results for predicate and new device are essentially the same. Applied's performance and functional testing demonstrated that the subject specimen retrieval system is substantially equivalent to the predicate device of K060051 and introduces no new safety and effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Applied Medical Inzii110 Retrieval System K060051
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.
0
Kiouss
APR 2 2 2010
Image /page/0/Picture/2 description: The image shows the logo for Applied Medical. The logo consists of the word "Applied" in large, bold letters, with the word "Medical" underneath in a smaller font. To the right of the text is a stylized graphic of a triangle with curved lines inside, possibly representing a mountain or a stylized medical symbol. The logo is black and white.
510(k) SUMMARY
Applied Medical Resources Corporation SUBMITTED BY: 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 (949) 713-8000 (949) 713-8205 (FAX)
CONTACT PERSON: Frans VandenBroek
DATE OF PREPARATION: February 9, 2010
TRADE NAME: Retrieval System
COMMON NAME: Tissue bags
CLASSIFICATION NAME: Laparoscope, General & Plastic Surgery (21CFR 876.1500. product code GCJ)
PREDICATE DEVICE: Applied Medical Inzii110 Retrieval System
DEVICE DESCRIPTION: The Applied medical specimen Retrieval System is a disposable receptacle used to collect and extract tissue, organs and calculi during laparoscopic procedures. It consists of a flexible polymer bag and an introducer structure that fits through a trocar port. Extracorporeal activation of the introducer handle ejects the flexible bag which automatically opens in preparation for receipt of the specimen. The device is constructed of various polymers and stainless steel. It is packaged in a Tyvek/Mylar peel pouch and a product shelf pack. The shelf pack will be sterilized using gamma irradiation per AAMI/ISO guidelines. Sterility Assurance Level will be 10°.
INTENDED USE: The Applied Medical specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The new device is a downsized version of the predicate and is designed to broaden Applied Medical's retrieval system product line. Both predicate and subject device a tissue bag and a delivery system consisting of an introducer tube and an ejection handle. Predicate and new device are constructed of the same materials and the design is similar except for a reduction in introducer tube diameter to accommodate placement through a smaller trocar. The subject device bag also has a smaller volume.
1
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K060051. These tests focused on functionality, robustness and bag strength. Test results for predicate and new device are essentially the same.
CONCLUSIONS DRAWN FROM TESTING: Applied's performance and functional testing demonstrated that the subject specimen retrieval system is substantially equivalent to the predicate device of K060051 and introduces no new safety and effectiveness issues.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, rendered in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Applied Medical Resources % Underwriters Laboratories, Inc. Casey Conry Senior Project Engineer 1285 Walt Whitman Road Melville, New York 11747
APR 2 2 2010
Re: K100959
Trade/Device Name: Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 05, 2010 Received: April 07, 2010
Dear Casey Conry:
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
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Page 2 - Casey Conry
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): Not yet assigned
Device Name: Specimen Retrieval System
Indications for Use: The Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Doylen for MKM
(Division Sign-Off)
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Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100959
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