(182 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a surgical tissue retrieval bag, with no mention of AI or ML.
No
The device is used for the removal of tissue, organ, or specimens during surgery, not for treating a disease or condition.
No
Explanation: The device is described as a "Lap Bag with fabric pouch system" used for the "safe and convenient removal of the tissue, organ or specimen during surgery." Its function is to isolate and contain tissue specimens. This is a surgical accessory for specimen retrieval, not a device that analyzes or diagnoses medical conditions.
No
The device description explicitly states it is a "TPU and nylon bonded fabric pouch" and a "single-use, sterile, and biocompatible laparoscopic accessory device," indicating it is a physical 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 "safe and convenient removal of the tissue, organ or specimen during surgery." This describes a surgical accessory used for physical manipulation and containment of biological material during a procedure.
- Device Description: The description focuses on the physical characteristics of the bag (TPU and nylon bonded fabric pouch) and its function in isolating and containing specimens during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs are typically used to analyze samples like blood, urine, or tissue to detect diseases, conditions, or infections.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, shelf life, loading capacity, and leak resistance. These are relevant to a surgical device, not an IVD which would typically have performance studies related to analytical and clinical performance (e.g., sensitivity, specificity).
In summary, the Lap Bag with fabric pouch system is a surgical device used for specimen retrieval during minimally invasive procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of the tissue, organ or specimen during surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Lap Bag with fabric pouch is applied in minimally invasive abdominal procedures for the safe and convenient removal of tissue, organ or specimens during surgery.
The device is a TPU and nylon bonded fabric pouch that minimizes spillage and intraoperative contamination by isolating and containing tissue specimens. It is designed for introduction and use through 11/12 and 15mm cannula.
The product is a single-use, sterile, and biocompatible laparoscopic accessory device. It is packaged by the Tyvek® 1073B sterile pouch and its shelf life is 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
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)
A series of studies were performed to evaluate the safety and effectiveness of Lap Bag with Fabric Pouch.
A. Biocompatibility Testing: Tests performed include:
- Cytotoxicity Test (ISO 10993-5:2009) - Pass
- Sensitization Test (ISO 10993-10:2010) - Pass
- Intracutaneous reactivity Test (ISO 10993-10:2010) - Pass
- Acute Systemic Toxicity Test (ISO 10993-11:2017) - Pass
- Material-Mediated Pyrogenicity Test (USP ) - Pass
All tests showed that Lap Bag with Fabric Pouch did not raise any safety issues and is biocompatible.
B. Sterilization Validation and Shelf Life Study:
a. Ethylene oxide Sterilization Validation Study: Performed per ISO 11135:2014, ISO 11737-1:2018, and ISO 11737-2:2019. Verified to meet SAL 10-6.
b. Product Aging Validation Study (Shelf Life Study): Performed for 3 years per ISO 11607-1:2019. Included:
- Package Integrity Test (Dye penetration Test) (ASTM F1929-15) - Pass
- Seal Peel Strength Test (ASTM F88/F88M-15) - Pass
- Product Sterility Test (ISO 11737-2:2019) - Pass
All aging test data showed that the product is safe and effective during its predetermined shelf life of 3 years.
C. Product Performance Test: Included:
- loading capacity test (internal testing protocol) - Pass
- leak-resistant test (internal testing protocol) - Pass
All test data showed that the Loading capacity test and Leakage-resistant function meet the requirements.
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.
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.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2021
Advanced Medical Design Co., Ltd. Mr. Jose Wang Regulatory Affair 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City, 248 Taiwan, R.O.C.
Re: K210248
Trade/Device Name: Lab Bag with Fabric Pouch Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 6, 2021 Received: June 9, 2021
Dear Mr. Wang:
We have reviewed vour 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.
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
1
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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Indications for Use
510(k) Number (if known) K210248
Device Name Lap Bag with Fabric Pouch
Indications for Use (Describe)
The Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of the tissue, organ or specimen during surgery.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. SUBMITTER
| Company Name: | Advanced Medical Design Co., Ltd. |
|---|---|
| Phone: | +886-2-2290-2627 |
| Fax: | +886-2-2298-1789 |
| Contact Person: | Mr. Jose Wang |
| Regulatory Affair Specialist | |
| Phone: +886-2-2290-2627 Ext. 511 | |
| E-mail: jose.wang@amdintl.com.tw | |
| Mailing Address: | 4F~5F, No29, Wuquan 5th Rd., Wugu Dist., New Taipei city, 248 Taiwan |
| R.O.C. | |
| Date Prepared: | July. 28, 2021 |
II. DEVICE INFORMATION
| Name of Device: | Lap Bag with Fabric Pouch | |
|---|---|---|
| Device Classification Name: | Laparoscope, General & Plastic Surgery | |
| Regulation Number: | 21 CFR 876.1500 | |
| Regulatory Class: | II | |
| Product Code: | GCJ |
III. PREDICATE DEVICE
| Trade/Device Name | Laparoscopic Tissue Retrieval Bag, Model 24003-MF |
|---|---|
| 510(k) Number | K123728 |
| Product Code | GCJ |
| Submitter | FLEXBAR MACHINE CORP. |
IV. DEVICE DESCRIPTION
The Lap Bag with fabric pouch is applied in minimally invasive abdominal procedures for the safe and convenient removal of tissue, organ or specimens during surgery.
The device is a TPU and nylon bonded fabric pouch that minimizes spillage and intraoperative contamination by isolating and containing tissue specimens. It is designed for introduction and use through 11/12 and 15mm cannula.
The product is a single-use, sterile, and biocompatible laparoscopic accessory device. It is packaged by the Tyvek® 1073B sterile pouch and its shelf life is 3 years.
V. INDICATIONS FOR USE
The Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of tissue, organ or specimens during surgery.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
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The substantial equivalent comparison table was summarized in Table 5.1.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Lap Bag with Fabric Pouch | Laparoscopic Tissue Retrieval Bag, |
| Model 24003-MF | ||
| 510(k) Number | TBD | K123728 |
| 510(k) Submitter | Advanced Medical Design Co., Ltd. | FLEXBAR MACHINE CORP. |
| Indications for Use | ||
| and Intended Use | The Lap Bag with fabric pouch system | |
| is applied in minimally invasive | ||
| abdominal procedures for the safe | ||
| and convenient removal of the tissue, | ||
| organ or specimen during surgery. | The Mediflex device is a laparoscopic | |
| tissue retrieval bag model 24003-MF. | ||
| The sterile bag is a single use | ||
| disposable device used as a receptacle | ||
| for collection and extraction of tissue | ||
| during laparoscopic surgical | ||
| procedures. | ||
| Product Code | GCJ | GCJ |
| Prescription / over- | ||
| the counter use | Prescription use | Prescription use |
| Reusable / Disposable | Single use | Single use |
| Function | To isolate and contain tissue | |
| specimens. | Collection, extraction of tissue via 10 | |
| mm, 11 mm or 12 mm cannula | ||
| Compatibility with | ||
| Other Devices | 11/12 and 15mm cannula | 10 mm, 11 mm or 12 mm cannula |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 |
| Sterile Barrier | Tyvek® Pouch | Tyvek® Pouch |
| Sterilization Method | ISO 11135-1 EO method (SAL: 10-6) | ISO 11135-1 EO method (SAL: 10-6) |
| Bag Material | TPU and Nylon | PU coated on nylon polyamide |
| Open / Close Method | Instruction | |
| Section 13 | Instruction | |
| Durability / Shelf Life | ISO 11607 / 3 years shelf | ISO 11607 / 5 years shelf |
| Nature of body | ||
| contact / Duration | Tissue, Blood / Pyrogen Test | Pass |
All of the test studies listed above showed that Lap Bag with Fabric Pouch did not raise any safety issues and is biocompatible.
B. Sterilization Validation and Shelf Life Study
The product is designed to perform Ethylene oxide sterilization prior to place into the market, therefore the following studies should be evaluated by the applicable standards/guidance.
a. Ethylene oxide Sterilization Validation Study
The Ethylene oxide sterilization study was performed per the requirements of the FDA recognized consensus standards listed below.
-ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices -ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
-ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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The product is sterilized using established E.O. sterilize Service Corporation. Using "Over Kill Half Cycle" based on ISO 11135:2014 to verify whether Lap Bag with Fabric Pouch meets the requirements of SAL 10-6.
b. Product Aging Validation Study (Shelf Life Study)
The product aging validation study was performed for 3 years per the FDA recognized consensus standards "ISO 11607-1:2019 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems" to determine the shelf life of the product, since the product is supplied in the sterile status.
The Aging Validation Study included the following test studies.
Since the shelf life of the product is proposed to be stored for 3 years, the aging validation study is performed which included the following test items.
| No. | Test Name | Applicable Standards | Comment |
|---|---|---|---|
| 1 | Package Integrity Test | ||
| (Dye penetration Test) | ASTM F1929-15:2015 Standard Test Method for | ||
| Detecting Seal Leaks in Porous Medical Packaging by Dye | |||
| Penetration | Pass | ||
| 2 | Seal Peel Strength Test | ASTM F88/F88M-15:2015 Standard Test Method for | |
| Seal Strength of Flexible Barrier Materials | Pass | ||
| 3 | Product Sterility Test | ISO 11737-2:2019 Sterilization of medical devices - | |
| Microbiological methods - Part 2: Tests of sterility | |||
| performed in the definition, validation and | |||
| maintenance of a sterilization process | Pass |
All of the aging test data showed that the product can be safe and effective during its predetermined shelf life. Hence, the sterile assurance level and the functional specification of the product meet the firm's definition and regulatory requirement, the shelf life of the product is 3 years.
C. Product Performance Test
Performance Bench testing was performed to verify the performance to specifications of the proposed device and included the following:
| No. | Test Name | Applicable Standards | Comment |
|---|---|---|---|
| 1 | loading capacity test | N/A (followed by the internal testing protocol) | Pass |
| 2 | leak-resistant test | N/A (followed by the internal testing protocol) | Pass |
All of the test data showed that the Loading capacity test and Leakage-resistant function of all Lap Bag with Fabric Pouch meet the requirement.
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VIII. Conclusion
The Lap Bag with Fabric Pouch has the same technological characteristics and intended uses as the predicate 24003-MF (K123728); and
The labeling of the Lap Bag with Fabric Pouch is concordant with the predicate device and FDA requirements; and
The information submitted to the FDA for the Lap Bag with Fabric Pouch does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
Therefore, the Lap Bag with Fabric Pouch is substantially equivalent to the predicate device.