(139 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical specimen retrieval bag, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is described as a receptacle for the collection of tissue, organs, and calculi, which is a supportive function during a medical procedure, not a direct treatment or diagnosis.
No
The device is described as a receptacle for the collection of tissue, organs, and calculi during procedures, indicating a function for retrieval rather than diagnosis.
No
The device description clearly outlines physical components (retracted bag, opening support, introducer shaft, etc.) and the performance studies focus on physical properties and tests (tensile strength, penetration force, leak test), 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 "as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures." This describes a device used during a surgical procedure to collect specimens.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description of the Specimen Retrieval Bag aligns with a surgical tool for collecting specimens, not a diagnostic test.
- Performance Studies: The performance studies focus on the physical properties and functionality of the bag (peeling force, tensile strength, leak test, etc.), which are relevant to its use as a collection device during surgery, not to its ability to perform a diagnostic test on a sample.
The device is a surgical accessory used for specimen collection, not a diagnostic test performed on those specimens.
N/A
Intended Use / Indications for Use
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
Product codes
GCJ
Device Description
The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
-
ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
The performance tests were performed on both proposed device and predicate device. The test items include follow items
-
Retracted Bag Peeling Force Test
-
String Tensile Strength Test
-
Force to Withdraw Retracted Bag Test
-
Force to Push out Retracted Bag Test
-
Penetration Force Test
-
Leak Test
No clinical study is included in this submission.
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 1, 2018
Beijing HangTian KaDi Technology R&D Institute % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K172789
Trade/Device Name: Specimen Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 5, 2018 Received: January 11, 2018
Dear Diana Hong:
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, 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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Specimen Retrieval Bag
Indications for Use (Describe)
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K172789
-
- Date of Preparation: 01/05/2018
-
- Sponsor Identification
Beiiing HangTian KaDi Technology R&D_Institute
Room 301-08, 09, 10, 11, Third floor, Building No.13, No.15 Jing Sheng Nan Er Street, TongZhou District, 101102 Beijing, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: Not yet registered
Contact Person: Liying Zhang Position: General Manager Tel: +86-10-56407751 Fax: +86-10-56407795-803 Email: zly1110@139.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co.. Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Specimen Retrieval Bag Common Name: Specimen Retrieval Bag
Regulatory Information
Classification Name: Laparoscope, General& Plastic Surgery Classification: II; Product Code: GCJ Regulation Number: CFR 876.1500 Review Panel: General& Plastic Surgery
Intended Use Statement:
The device is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic procedures.
Device Description
The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.
-
ર. Identification of Predicate Device
510(k) Number: K100959 Product Name: Specimen Retrieval System -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
5
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
-
ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
The performance tests were performed on both proposed device and predicate device. The test items include follow items
-
Retracted Bag Peeling Force Test
-
String Tensile Strength Test
-
Force to Withdraw Retracted Bag Test
-
Force to Push out Retracted Bag Test
-
Penetration Force Test
-
Leak Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
| Item | Proposed Device | Predicate Device |
|---|---|---|
| K100959 | ||
| Product Code | GCJ | Same |
| Regulation Number | 21 CFR 876.1500 | Same |
| Class | CLASS II | Same |
| Intended Use | The specimen retrieval bag is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures. | Same |
| Configuration | Retracted Bag | Same |
| Outer Introducer Shaft | ||
| Outer Introducer Handle | ||
| Inner Introducer Shaft | ||
| Inner Introducer Handle | ||
| String | ||
| Opening Support | ||
| Pull loop | ||
| Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Same |
| Sterilization | EO sterilization | Irradiation Sterilization |
| Biocompatibility | ||
| Cytotoxicity | No cytotoxicity | Conform with ISO 10993 |
| requirements | ||
| Skin Sensitization | No skin sensitization | |
| Irritation | No irritation |
8. Substantially Equivalent (SE) Comparison
- Table 1 Comparison of Technology Characteristics
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.