(13 days)
Not Found
Not Found
No
The description focuses on the physical characteristics, packaging, sterilization, and intended use as a receptacle, with no mention of AI or ML capabilities.
No
The device is described as a receptacle for collecting and extracting tissue, organs, and calculi during surgical procedures, not for treating or rehabilitating a medical condition.
No
The device is described as a receptacle for collecting and extracting tissue, organs, and calculi during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a disposable, single-use physical device used as a receptacle, indicating it is hardware.
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).
- Device Description: The description focuses on the physical characteristics, packaging, and sterilization of a surgical device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, performing tests, or providing diagnostic information. The device is purely for retrieval and containment.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the surgical procedure itself.
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 indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Specimen Retrieval System has been found non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices.
The Specimen Retrieval System is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.
The Applied Medical disposable Specimen Retrieval System will be sterilized using Cobalt 60 Gamma Radiation, AAMI/ISO Guideline for Radiation Sterilization will be utilized to provide a Sterility Assurance Level of 10-6.
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)
Not Found
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
JAN 1 9 2006
K 06005/
510(k) SUMMARY
PENDING
510(k) NUMBER:
SUBMITTED BY:
Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 (949) 713-8327
CONTACT PERSON:
Cheryl Blake V.P. Regulatory Affairs and Quality Systems
Endoscope and Accessories 21 CFR 876.1500
DATE OF PREPARATION: December 20, 2005
NAME OF DEVICE: Specimen Retrieval System
CLASSIFICATION NAME:
TRADE NAME: Not Determined
SUMMARY STATEMENT: 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.
The Specimen Retrieval System has been found non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices.
The Specimen Retrieval System is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.
The Applied Medical disposable Specimen Retrieval System will be sterilized using Cobalt 60 Gamma Radiation, AAMI/ISO Guideline for Radiation Sterilization will be utilized to provide a Sterility Assurance Level of 106.
The Specimen Retrieval System is substantially equivalent to predicate devices in design methodology, principle of operation and clinical utility. The device introduces no new safety or effectiveness issues when used as instructed.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
Applied Medical Resources c/o Mr. Morten Simon Christensen Staff Engineer and FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road San Jose, California 95131-1230
Re: K060051
Trade/Device Name: Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 5, 2006 Received: January 6, 2006
Dear Mr. Christensen:
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 10 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
2
Page 2 - Mr. Christensen
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bvehum
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Applied Medical Specimen Retrieval System "Indications for Use" as required.
Not assigned 510(k) Number:
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.
Signature: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Name: Cheryl Blake Title: V.P. Regulatory Affairs and Quality Systems Date: 11/28/2005
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format -2-96) |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K060051 |
|---|---|
| --------------- | --------- |