(182 days)
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 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.
The provided document is a 510(k) Summary for a medical device called "Lap Bag with Fabric Pouch". It describes the device, its intended use, and substantial equivalence to a predicate device, supported by performance data. However, it does not include specific quantitative acceptance criteria or a detailed study directly proving the device meets those criteria in the way typically found in clinical trials or software validation studies.
This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Laparoscopic Tissue Retrieval Bag, Model 24003-MF, K123728) through various engineering and scientific tests, rather than clinical performance metrics with specific acceptance thresholds.
Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are not present in this type of regulatory submission for this particular device.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of "acceptance criteria" alongside specific "reported device performance" in a quantitative manner as one might expect for diagnostic accuracy or clinical outcomes. Instead, it lists various tests performed and states whether the device "Pass"ed them. The implicit acceptance criteria are typically compliance with the referenced standards or internal protocols, and the reported performance is simply passing these tests.
| Test Name | Applicable Standards/Protocol | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing | |||
| Cytotoxicity Test | ISO 10993-5:2009 | No significant cytotoxic effects | Pass |
| Sensitization Test | ISO 10993-10:2010 | No significant sensitization | Pass |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 | No significant irritation/reactivity | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 | No significant systemic toxic effects | Pass |
| Material-Mediated Pyrogenicity Test | USP <151> | Non-pyrogenic | Pass |
| Sterilization Validation & Shelf Life Study | |||
| Ethylene oxide Sterilization Validation Study | ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2019 | Achieve Sterility Assurance Level (SAL) of 10-6 | Meets requirements |
| Package Integrity Test (Dye penetration Test) | ASTM F1929-15:2015 | Maintain sterile barrier integrity | Pass |
| Seal Peel Strength Test | ASTM F88/F88M-15:2015 | Maintain seal strength | Pass |
| Product Sterility Test | ISO 11737-2:2019 | Sterile | Pass |
| Product Performance Test | |||
| Loading capacity test | N/A (followed by the internal testing protocol) | Meet specified internal capacity requirements (e.g., hold a certain weight/volume without tearing) | Pass |
| Leak-resistant test | N/A (followed by the internal testing protocol) | Maintain leak resistance (e.g., no fluid leakage under specified conditions) | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for individual tests. The tests are bench tests and laboratory validations, not human clinical trials. Data provenance in terms of country of origin or retrospective/prospective is not applicable or stated for these types of engineering and biocompatibility tests. The manufacturer, Advanced Medical Design Co., Ltd., is based in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the types of tests reported. The "ground truth" for these tests are the objective results of standard laboratory procedures (e.g., measuring cytotoxicity, sterile barrier integrity, or leak resistance) against predefined ISO or ASTM standards or internal protocols. No human experts are described as establishing "ground truth" in the context of these evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a physical medical device (a laparoscopic retrieval bag), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the various tests are based on:
- Biocompatibility: Standardized biological assays and in vivo tests as per ISO 10993 series and USP <151> standards, which have objective endpoints.
- Sterilization Validation: Microbiological testing and physical indicators to verify a Sterility Assurance Level (SAL) of 10-6, according to ISO 11135 and ISO 11737.
- Shelf Life Study: Physical testing of packaging integrity (dye penetration, seal peel strength) and product sterility after accelerated or real-time aging, per ASTM F1929, ASTM F88/F88M, and ISO 11737.
- Product Performance Tests (Loading Capacity, Leak-resistant): Verification against internal testing protocols, implying objective measurement against predefined specifications.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
{0}------------------------------------------------
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
{2}------------------------------------------------
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)
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 Drug 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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side of the letter A. The letters AMD are in bold, and the text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is below the letters.
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 WangRegulatory Affair SpecialistPhone: +886-2-2290-2627 Ext. 511E-mail: jose.wang@amdintl.com.tw |
| Mailing Address: | 4F~5F, No29, Wuquan 5th Rd., Wugu Dist., New Taipei city, 248 TaiwanR.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
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side of the letter A. The letters AMD are in bold, and the text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is below the letters.
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 Useand Intended Use | The Lap Bag with fabric pouch systemis applied in minimally invasiveabdominal procedures for the safeand convenient removal of the tissue,organ or specimen during surgery. | The Mediflex device is a laparoscopictissue retrieval bag model 24003-MF.The sterile bag is a single usedisposable device used as a receptaclefor collection and extraction of tissueduring laparoscopic surgicalprocedures. |
| Product Code | GCJ | GCJ |
| Prescription / over-the counter use | Prescription use | Prescription use |
| Reusable / Disposable | Single use | Single use |
| Function | To isolate and contain tissuespecimens. | Collection, extraction of tissue via 10mm, 11 mm or 12 mm cannula |
| Compatibility withOther 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 | InstructionSection 13 | Instruction |
| Durability / Shelf Life | ISO 11607 / 3 years shelf | ISO 11607 / 5 years shelf |
| Nature of bodycontact / Duration | Tissue, Blood / <24 hr | Tissue, Blood / <24 hr |
| Nature of Body Contact | ||
| Category | Contact | Contact Duration |
| External communicating device | Tissue/bone/dentin | Limited (≤24 h) |
Table 5.1. The Substantial Equivalent Comparison Table
Through the substantially equivalent comparison table, the differences do not raise any different issues on the safety or effectiveness of the product.
VII. PERFORMANCE DATA
A series of the studies were performed to evaluate the safety and effectiveness of Lap Bag with Fabric Pouch. The following test results were provided to confirm the product is safe and effective as
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side. The letters AMD are in large, bold font. Below the letters is the text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" in a smaller font.
indicated.
A. Biocompatibility Testing
The biocompatibility test was evaluated per the FDA recognized consensus standard named "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016, the biocompatibility tests include the following items since the product is classified as the classification.
| No. | Test Name | Applicable Standards | Comment |
|---|---|---|---|
| 1 | Cytotoxicity Test | ISO 10993-5:2009 Biological evaluation of medical devices— Part 5: Tests for in vitro cytotoxicity | Pass |
| 2 | Sensitization Test | ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Pass |
| 3 | Intracutaneousreactivity Test | ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Pass |
| 4 | Acute SystemicToxicity Test | ISO 10993-11:2017 Biological evaluation of medical devices— Part 11: Tests for systemic toxicity | Pass |
| 5 | Material-MediatedPyrogenicity Test | USP <151> 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
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for AMD Global Solutions for the Medical Industry. The logo is in blue and features a globe on the left side of the letters AMD. The text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is located below the logo.
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 forDetecting Seal Leaks in Porous Medical Packaging by DyePenetration | Pass |
| 2 | Seal Peel Strength Test | ASTM F88/F88M-15:2015 Standard Test Method forSeal Strength of Flexible Barrier Materials | Pass |
| 3 | Product Sterility Test | ISO 11737-2:2019 Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterilityperformed in the definition, validation andmaintenance 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.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for AMD, which is a global solutions provider for the medical industry. The logo is in blue and features a globe on the left side, followed by the letters AMD in bold. Below the logo, the text "GLOBAL SOLUTIONS FOR MEDICAL INDUSTRY" is written in a smaller font.
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.
§ 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.