(87 days)
Not Found
No
The device description and performance studies indicate a purely mechanical, manual instrument for surgical suturing. There is no mention of software, data processing, or any features that would suggest AI/ML involvement.
No.
This device is used for approximation of tissues and closing incision sites, which is a surgical tool function, not for treatment or diagnosis of disease.
No
The device description clearly states its purpose is for "approximation of tissues and percutaneous suturing for closing incision sites," and it's used as a "manual instrument to pass needles with suture through soft tissues for suturing." These actions are therapeutic, not diagnostic.
No
The device description clearly outlines physical components (Suture Guide, Suture Passer, Handle, Suture Catcher, Needle, Suture Shaft) and describes their mechanical function in a surgical procedure. There is no mention of software as a component or its function.
Based on the provided information, the AbClose - Port Site Closure Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation of tissues and percutaneous suturing for closing incision sites" during laparoscopic procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a manual surgical instrument used to pass sutures through soft tissues. It is used during a surgical procedure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status. IVDs are designed for this type of testing.
The device is a surgical tool used for a specific step in a surgical procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Product codes (comma separated list FDA assigned to the subject device)
OCW, GCJ, HCF
Device Description
The AbCloseTM - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.
The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominopelvic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: Clinician who is qualified to participate a laparoscopic surgery.
Care Setting: Hospital O.R. room
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 performance testing for the design modification demonstrated substantial equivalence to the previously cleared predicate:
Biocompatibility testing: Per material change, the biocompatibility evaluation and testing of the AbCloseTM - Port Site Closure Device was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- FDA Guidance Use of International Standard ISO 10993-1, "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 10993-10:2009, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
- United State Pharmacopeia (USP) Chapter Rabbit Pyrogen Test
Mechanical testing: The modified device's mechanical function and structure integrity were tested and demonstrated that the design specification from design input were fulfilled and the design modifications did not alter the device safety and function. The following mechanical tests have been successfully performed with the same test methods as for the predicate device, and all the results were passed, including Suture Guide Push Button Test, Suture Guide Slider Test, Suture Guide Durability Test, Suture Guide Front Upper Cover Bonding Test, Suture Guide Front Lower Cover Bonding Test, Suture Passer Suture Button Test, Suture Passer Suture Release Button Test, Suture Passer Penetration Test, Suture Passer Cover Bonding Test, Suture Deployment Test, Suture Guide Lock Mechanism Test, and Accelerated Aging test of sterile barrier system. In addition to the original tests conducted for the predicate device, three new tests have been conducted to verify the effectiveness of the modifications made in the modified device, including Suture Guide Suture Catcher Torque Test, Suture Passer Needle Retention Force Test, and Suture Passer Needle Torque Test. These mechanical tests have been successfully performed, and all the results were passed.
Functional testing: Device functionality was tested in the animal model to demonstrate that the intended use was fulfilled. Design modifications did not alter the device function and intended use. The animal study has been successfully performed with the same test method as that used for the predicate device, and the result was passed.
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
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 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.
March 26, 2020
Medeon Biodesign, Inc. Tsung-Yu Hsieh Sr. Specialist of Regulatory, Quality and Clinical Affairs 7F, 116, HouGang St., Taipei, 11170 Tw
Re: K193652
Trade/Device Name: AbClose - Port Site Closure Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCW, GCJ, HCF Dated: December 26, 2019 Received: December 30, 2019
Dear Ms. Hsieh:
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.
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
1
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 (OS) 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 medical devices and radiation-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,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K193652
Device Name AbClose - Port Site Closure Device
Indications for Use (Describe)
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| Requisition Use (Part 21 CFR 601.21 and Part On-The-Market Use (21 CFR 601.2 and | Requisition Use (Part 21 CFR 601.21 and Part | Requisition Use (Part 21 CFR 601.21 and Part | On-The-Market Use (21 CFR 601.2 and | On-The-Market Use (21 CFR 601.2 and |
| Requisition Use (Part 21 CFR 601.21 and Part | Requisition Use (Part 21 CFR 601.21 and Part | On-The-Market Use (21 CFR 601.2 and | On-The-Market Use (21 CFR 601.2 and | |
| Requisition Use (Part 21 CFR 601.21 and Part | ||||
| On-The-Market Use (21 CFR 601.2 and |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.
| The assigned 510(k) Number: K193652 | |
|---|---|
| Date Prepared: | March 4, 2020 |
| 1 | Submitter | |
|---|---|---|
| Mailing | ||
| Address | Medeon Biodesign, Inc | |
| 7F, 116, HouGang St, | ||
| Taipei, Taiwan 11170 | ||
| Phone: +886 2 2881 6686 | ||
| Establishment Registration No.: 3012452802 | ||
| Contact Person | Tsung-Yu, Hsieh | |
| Sr. Specialist of Regulatory, Quality & Clinical Affair | ||
| Phone: | +886 2 2881 6686 ext.130 | |
| Fax: | +886 2 2881 6907 | |
| E-mail: | tsungyu.hsieh@medeonbio.com |
2 Device Name
| Common or
| Usual Name | Endoscopic tissue approximation device |
|---|---|
| Trade Name | AbCloseTM - Port Site Closure Device |
| Product Code | OCW, GCJ, HCF |
| Device | Endoscope and accessories |
| CFR | |
| Classification | CFR Part 876.1500 |
| Device Class | II |
| Classification | |
| Panel | Gastroenterology/Urology |
- 3 Predicate k number
The AbClose™ - Port Site Closure Device is a sterile, single-use 4 Device Description: device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.
The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold
4
the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site. The AbClose™ - Port Site Closure Device is intended to be used by clinicians through prescription use only. The AbClose™ - Port Site Closure Device has application in 5 Indications for Use: laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites. Special For prescription use only Conditions for Use Statement(s): 6 Technological Modifications to design and material of the previously 510(k) cleared AbClose™ - Port Site Closure Device (K160117) to close the incision Characteristics created by 10 - 15mm trocar. The modifications include: and Substantial 1. Dimensional change: Change component dimension to improve the functionality of device, simplify the production process and Equivalence Comparison improve manufacturability. 2. Material change: Change material of Slider to improve with Predicate: manufacturability and use material of Button Lock with higher tensile and flexural strength. 3. Add visualization feature: Add visualization windows on Slider and add indication marks on Handle of Suture Passer and Suture Guide. 4. Package change: Dimensional and structure change of packaging components includes reducing the size of sterile barrier system, modifying the securing features of Blister, add Lid of Blister and reduce the size and change the structure of protective packaging material. A comparison of the device features, intended use, and other information demonstrates that the modified device is substantially equivalent to the predicate device as summarized in Table 1. The differences raise no different questions of safety or effectiveness.
5
| Table 1: Substantially Equivalent Table | ||
|---|---|---|
| Similarities | ||
| Device name | Predicate device: | |
| AbCloseTM - Port Site Closure | ||
| Device (Model: M12) | ||
| (K160117) | Modified device: | |
| AbCloseTM - Port Site Closure | ||
| Device (Model: M12) | ||
| Indications | ||
| for use | The AbCloseTM - Port Site | |
| Closure Device has application | ||
| in laparoscopic procedures for | ||
| approximation of tissues and | ||
| percutaneous suturing for | ||
| closing incision sites. | Same | |
| Target patient | ||
| Population | Patient under laparoscopic | |
| surgery | Same | |
| Target User | ||
| Population | Clinician who is qualified to | |
| participate a laparoscopic surgery. | Same | |
| Anatomical | ||
| Site | Abdominopelvic cavity | Same |
| Where Used | Hospital O.R. room | Same |
| Contraindicatio | ||
| ns | Do not use where laparoscopic | |
| techniques are generally | ||
| contraindicated | Same | |
| Method of | ||
| Introduction | -Suture Guide is introduced into | |
| abdominopelvic cavity via a 10 – | ||
| 15 mm trocar port site | ||
| -Suture Passer is introduced into | ||
| abdominopelvic cavity by insertion | Same | |
| Performance | Maintain pneumoperitoneum and | |
| facilitate placement and withdrawal | ||
| of suture loop | Same | |
| Biocompatible | ||
| for Intended | ||
| Use | Limited exposure, external | |
| communication device of tissue | ||
| contact. | Same | |
| Sterilization | ||
| Method | Ethylene Oxide sterilization, SAL | |
| of 10-6 | Same | |
| Energy source | No energy source | Same |
| Compatibility | Trocar: 10 – 15 mm | Same |
Table 1: Substantially Equivalent Table
7. Performance Testing
The following performance testing for the design modification demonstrated substantial equivalence to the previously cleared predicate:
Biocompatibility testing
Per material change, the biocompatibility evaluation and testing of the AbClose™ - Port Site Closure Device was conducted in accordance with the following standards and guidance, as recognized by the FDA:
6
- FDA Guidance Use of International Standard ISO 10993-1, "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 10993-10:2009, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2006, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
- . United State Pharmacopeia (USP) Chapter Rabbit Pyrogen Test
Mechanical testing
The modified device's mechanical function and structure integrity were tested and demonstrated that the design specification from design input were fulfilled and the design modifications did not alter the device safety and function. The following mechanical tests have been successfully performed with the same test methods as for the predicate device, and all the results were passed, including Suture Guide Push Button Test, Suture Guide Slider Test, Suture Guide Durability Test, Suture Guide Front Upper Cover Bonding Test, Suture Guide Front Lower Cover Bonding Test, Suture Passer Suture Button Test, Suture Passer Suture Release Button Test, Suture Passer Penetration Test, Suture Passer Cover Bonding Test, Suture Deployment Test, Suture Guide Lock Mechanism Test, and Accelerated Aging test of sterile barrier system. In addition to the original tests conducted for the predicate device, three new tests have been conducted to verify the effectiveness of the modifications made in the modified device, including Suture Guide Suture Catcher Torque Test, Suture Passer Needle Retention Force Test, and Suture Passer Needle Torque Test. These mechanical tests have been successfully performed, and all the results were passed.
Functional testing
Device functionality was tested in the animal model to demonstrate that the intended use was fulfilled. Design modifications did not alter the device function and intended use. The animal study has been successfully performed with the same test method as that used for the predicate device, and the result was passed.
8. Conclusion
Based on the intended use, technological characteristics, performance testing and comparison to the predicate device, the modified device is substantially equivalent to the predicate device and raises no different questions of safety or effectiveness.