(105 days)
Not Found
No
The summary describes a sterile specimen retrieval pouch and its physical characteristics and performance tests, with no mention of AI or ML technology.
No
The device is described as a "receptacle for the collection of tissue, organs and calculi" and a "specimen retrieval pouch," which indicates it is used for containing and removing biological material during surgery, not for treating a disease or condition.
No
The device is described as a receptacle for collecting tissue, organs, and calculi during surgical procedures, and a specimen retrieval pouch. Its function is to contain specimens, not to diagnose conditions or process diagnostic information.
No
The device description clearly states it is a "Sterile Specimen Retrieval Pouch" and describes physical components like a "single use specimen container," "dispensing tube," and different "types: metal type, non-metal type, metal locking type, and non-metal locking type." This indicates a physical medical device, not a software-only one.
Based on the provided information, the LapBag® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "collection of tissue, organs and calculi during general and laparoscopic surgical procedures." This describes a surgical tool for specimen retrieval, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a "Sterile Specimen Retrieval Pouch" designed for use during laparoscopic surgery. This reinforces its role as a surgical accessory.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information. The device's function is purely mechanical – to collect and contain specimens.
IVD devices are typically used to perform tests on samples like blood, urine, or tissue outside the body to diagnose diseases or conditions. The LapBag®'s function is entirely within the surgical procedure itself.
N/A
Intended Use / Indications for Use
LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.
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)
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Sterilization Validation Test in accordance with ISO11737-1
- Shelf Life Validation Test
- Biocompatibility Tests in accordance with ISO 10993: Cytotoxicity (ISO 10993-5), Ethylene Oxide Sterilization Residuals (ISO 10993-7), Skin Sensitization (ISO 10993-10), Systemic Toxicity (ISO 10993-11), Irritation (ISO 10993-10)
- Performance Tests: Appearance, Measurement, Extraction Test, Puncture Resistance and Tensile Strength tests, Bag Leak Test, and Ring Pull Test
The major difference between the subject device and the predicate device is the sizes of pouch. LapBag® has a wider range of size than the predicate devices. We have performed the comparison test for Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test, and the test results support that the subject device is substantially equivalent to the predicate devices.
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2017
Sejong Medical Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc. 690 Roosevelt Irvine, California 92620
Re: K171726
Trade/Device Name: LapBag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 12, 2017 Received: September 19, 2017
Dear Priscilla Chung:
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 Actinclude 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv. Jennifer R. Stevenson -S3 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
LapBag®
Indications for Use (Describe)
LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*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
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3
510(k) Summary
(K171726)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 09/12/2017
1. Submitter/Applicant
Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880
Tel: +82-31-945-8191 Fax: +82-31-945-8190
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: LapBag®
- Common Name: Tissue Bags ●
- Classification: Class II
- Classification regulation: 21 CFR 876.1500 ●
- . Product Code: GCJ
Predicate Devices: 4.
Predicate Device:
MGB Disposable Retrieval Bag/LAPBAG (K093194) by MGB Endoskopische Gerate GmbH Berilin
5. Description:
Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is
4
designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.
Indication for use: 6.
LapBag® is intended for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
7. Performance Data
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- · Sterilization Validation Test in accordance with ISO11737-1
- · Shelf Life Validation Test
- · Biocompatibility Tests in accordance with ISO 10993
| Cytotoxicity | ISO 10993-5 |
|---|---|
| Ethylene Oxide Sterilization | |
| Residuals | ISO 10993-7 |
| Skin Sensitization | ISO 10993-10 |
| Systemic Toxicity | ISO 10993-11 |
| Irritation | ISO 10993-10 |
- · Performance Tests: Appearance, Measurement, Extraction Test, Puncture Resistance and Tensile Strength tests, Bag Leak Test, and Ring Pull Test
8. Basis for Substantial Equivalence
The subject device, LapBag® incorporates the same intended use with the predicate device. The devices are similar in physical & mechanical properties and dimensions.
The major difference between the subject device and the predicate device is the sizes of pouch. LapBag® has a wider range of size than the predicate devices. We have performed the comparison test for Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test, and the test results support that the subject device is substantially equivalent to the predicate devices.
5
9. Conclusion
Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the LapBag® is substantially equivalent to the predicate devices.