(63 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a specimen retrieval bag, with no mention of AI or ML.
No.
The device is described as a receptacle for collecting tissue, organs, and calculi, which are functions related to retrieval during surgical procedures, not to treating a disease or condition.
No
The device is described as a receptacle for collecting tissue, organs, and calculi during procedures, indicating a function for retrieval and containment, not diagnosis. The performance studies focus on physical and mechanical properties and sterility, not diagnostic capabilities.
No
The device description explicitly lists multiple physical components (retracted bag, steel sheet, plug, etc.) and the performance studies focus on physical properties and testing (tensile strength, penetration force, leak test, sterilization, biocompatibility). There is no mention of software.
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, not a device used in vitro (outside the body) to analyze biological samples for diagnostic purposes.
- Device Description: The description details a physical bag and associated components for retrieval, not a system for analyzing biological materials.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical integrity and functionality of the bag and its components.
Therefore, this device is a surgical instrument for specimen collection, not an in vitro diagnostic device.
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, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 performance tests were performed on both proposed device and predicate device. The test items include: A Retracted Bag Peeling Force Test, Tightening Line Tensile Strength Test, Force to Push out Retracted Bag Test, Force to Withdraw Retracted Bag Test, Penetration Force Test, Leak Test. Sterile Barrier Packaging Testing performed on the proposed device included: Visual Inspection, Seal strength, Dye penetration. Sterilization and Shelf Life Testing performed on the proposed device included: EO residue, ECH residue, Shelf Life Evaluation. The biocompatibility evaluation was conducted in accordance with "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" June, 2016, and ISO 10993-1. The proposed device was evaluated for Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic Toxicity, Pyrogen.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
July 10, 2020
Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K201243
Trade/Device Name: Disposable Specimen Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 22, 2020 Received: May 8, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Disposable 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Tab #6 510(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: __
-
- Date of Preparation: 04/22/2020
-
- Sponsor Identification
Beijing Biosis Healing Biological Technology Co., Ltd.
No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600 Beijing, China
Establishment Registration Number: 3016668451
Contact Person: Jiali Zhou Position: Regulatory Affair Tel: +86-10-61252660 Fax: +86-10-61252030 Email: zhoujiali@biosishealing.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Disposable Specimen Retrieval Bag Common Name: Specimen Retrieval Bag Models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-350, RJRB-420
Regulatory Information
Classification Name: Laparoscope, General& Plastic Surgery; Classification: II; Product Code: GCJ; Regulation Number: 21CFR 876.1500 Review Panel: General & Plastic Surgery;
Indication for Use:
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
Device Description
The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use
- ਟ. Identification of Predicate Device
510(k) Number: K172789 Product Name: Specimen Retrieval Bag
6. 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 performance tests were performed on both proposed device and predicate device. The test items include follow items
- A Retracted Bag Peeling Force Test
5
-
Tightening Line Tensile Strength Test
-
Force to Push out Retracted Bag Test
-
Force to Withdraw Retracted Bag Test
-
Penetration Force Test
-
Leak Test
Sterile Barrier Packaging Testing performed on the proposed device:
-
Visual Inspection
-
Seal strength
-
Dye penetration
Sterilization and Shelf Life Testing performed on the proposed device:
-
EO residue
-
ECH residue
-
Shelf Life Evaluation
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA guidance document "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" June, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The proposed device was evaluated for the following tests:
-
Cytotoxicity,
-
Sensitization,
-
Intracutaneous reactivity,
-
Systemic Toxicity,
-
Pyrogen
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| K172789 | ||
| Product Code | GCJ | GCJ |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 |
| Class | Class II | Class II |
| Indication for 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. | 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. | ||
| Configuration | Retracted bag | Retracted Bag |
| Steel sheet | Outer Introducer Shaft | |
| Plug | Outer Introducer Handle | |
| Inner sleeve | Inner Introducer Shaft | |
| Outer sleeve | Inner Introducer Handle | |
| Pull ring | String | |
| Outer introducer handle | Opening Support | |
| Joint | Pull loop | |
| Tightening line | ||
| Pick rod | ||
| Inter introducer handle | ||
| Single Use | Single Use | Single Use |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 |
| Retracted Bag | ||
| Size | Available in 90mm×100mm, 90mm | |
| ×120mm, 90mm×140mm, 90mm | ||
| ×160mm, 90mm×180mm, 110mm | ||
| ×120mm, 110mm×150mm, 110mm | ||
| ×180mm, 130mm×150mm, | ||
| 130mm×180mm | Available in 40 × 130mm, 60 × | |
| 150mm, 80 × 200mm, 100 × | ||
| 220mm, 130×250mm, 40×150mm, | ||
| 60×180mm, 80 × 220mm, 100× | ||
| 275mm, 130× 320mm | ||
| Retracted Bag | ||
| Volume | Available in 50ml, 100ml, 120ml, | |
| 150ml, 200ml, 250ml, 300ml, 320ml, | ||
| 350ml, 420ml | Available in 50ml, 100ml, 200ml, | |
| 300ml, 350ml, 400ml, 500ml, 600ml | ||
| Patient -contact material | ||
| Retracted Bag | Thermoplastic Polyurethane (TPU) | Thermoplastic Polyurethane (TPU) |
| Outer Introducer | ||
| Shaft | Polyvinyl chloride (PVC) | Polycarbonate (PC) |
| Inner | ||
| Introducer | ||
| Shaft | Polyvinyl chloride (PVC) | Polycarbonate (PC) |
| Steel sheet | 304 Stainless Steel | / |
| Plug | Acrylonitrile Butadiene styrene | |
| (ABS) | / | |
| Joint | Acrylonitrile Butadiene styrene | |
| (ABS) | / | |
| Ttightening line | Nylon | / |
| Pick rod | Polyvinyl chloride (PVC) | / |
| Biocompatibility | ||
| Cytotoxicity | No cytotoxicity | No cytotoxicity |
| Skin Sensitization | No skin Sensitization | No skin Sensitization |
| Irritation | No irritation | No irritation |
| Systemic Toxicity | No systemic Toxicity | No systemic Toxicity |
| Pyrogen | No pyrogen | No pyrogen |
| Sterilization | ||
| Method | EO sterilization | EO sterilization |
| SAL | 10-6 | 10-6 |
Table 1 Comparison of Technology Characteristics
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-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion