(234 days)
Not Found
No
The device description details a purely mechanical instrument for manual suturing, with no mention of computational analysis, algorithms, or learning capabilities.
No
The device is described as a surgical instrument used for closing incision sites and approximating tissues, not for treating any specific disease or condition. Its function is mechanical in nature, facilitating a step in a surgical procedure rather than having a direct therapeutic effect.
No
The device is described as a surgical instrument used for closing incision sites in laparoscopic procedures by passing sutures through soft tissues. It is not used for obtaining diagnostic information about a patient's health.
No
The device description clearly outlines physical components (Suture Guide, Suture Passer, Handle, Suture Catcher, Needle, Suture Shaft) and mechanical actions (folding, expanding, grasping, penetrating, deploying, withdrawing). The performance studies also focus on sterilization and mechanical testing of these physical components, not software validation.
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 in the operating room setting.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used within the abdominopelvic cavity, which is an in-vivo application.
- Performance Studies: The performance studies focus on sterilization, mechanical function, and animal testing to demonstrate the device's ability to perform its surgical function. There are no studies related to diagnostic accuracy or performance with biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological specimens for diagnostic purposes. The AbClose device is clearly designed for in vivo surgical use.
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. For prescription use only
Product codes (comma separated list FDA assigned to the subject device)
OCW, GCJ, HCF
Device Description
The AbClose - 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 fold 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
Clinician who is qualified to participate a laparoscopic surgery.
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)
Performance testing has been carried out to demonstrate that this device meets the performance specification for its intended use. The following tests were performed on the device:
- Sterilization validation: Sterilization validation was conducted in accordance with ISO 11135:2014 "Sterilization of health-care products-Ethylene oxide -Requirement for the development, validation and routine control of a sterilization process for medical devices". Sterilization has been validated to achieve a Sterility Assurance Level (SAL) of 10-6.
- Mechanical testing: Abclose - Port Site Closure Device's mechanical function and structure integrity were tested to demonstrate that the design specification from design input are fulfilled. Mechanical safety test were also conducted to demonstrate the insertion portion of the device remain intact during the surgery and raise no safety concern.
- Animal test: The intended use has been conducted by animal test to demonstrate the AbClose - Port Site Closure Device can deliver the intended function of application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Medeon Biodesign, Inc. Ms. Greta Chang Sr. Manager of Regulatory, Ouality & Clinical Affairs 7F, 116, HouGang St. Taipei Taiwan 11170 TW
Re: K160117
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: July 27, 2016 Received: July 28, 2016
Dear Ms. Greta Chang:
This letter corrects our substantially equivalent letter of September 9, 2016.
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 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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" (21CFR 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 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.
Sincerely,
David Krause -S
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
2
Indications for Use
510(k) Number (if known) K160117
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) | |
|---|---|
| ☑ 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
510(k) Summary
510(k) Nwmber Date Prepared
Submitter 1. Mailing Address
K160117 16 June 2016
Medeon Biodesign, Inc
7F, 116, HouGang St, Taipei, Taiwan 11170 Phone: +886 2 2881 6686
Contact Person
Phone: Fax: E-mail: Date Prepared
2 Device Name Common or usual name Trade name Product Code Classification Name CFR Classification Device Class Classification Panel
3 Predicate Device Name 510(k) number: Trade or proprietary or model name: Manufacturer:
4 Device Description: Greta Chang Sr. Manager of Regulatory, Quality & Clinical Affair +886 2 2881 6686 +886 2 2881 6685 greta@medeonbio.com
Endoscopic tissue approximation device AbClose-Port Site Closure Device OCW, GCJ, HCF Endoscope and Accessories CFR Part 876.1500 II Gastroenterology/Urology
K132362 WECK EFx Endo Fascial Closure System
Teleflex Medical, Incorporated
The AbClose - 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
4
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 fold 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.
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.
For prescription use only
A Comparison of the device feature, intended use, and other information demonstrates that the AbClose - Port Site Closure Device is substantially equivalent to the predicate device as summarized in Table 1.
All patient contacting materials are in compliance with ISO 10993-1, as well as FDA Draft Guidance - Use of international Standard ISO 10993, "Biological Evaluation of Medical Devices, Part1: Evaluation and Testing", dated 04-23-2013
న్.
Special Conditions for Use Statement(s):
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
-
- Materials
5
Table 1
| Similarities | ||
|---|---|---|
| Device name | Subject device: | |
| AbClose - Port Site Closure Device | Predicate device: | |
| WECK EFx Endo Fascial Closure | ||
| System | ||
| Indications for | ||
| use | The AbClose - Port Site Closure Device | |
| has application in laparoscopic | ||
| procedures for approximation of tissue | ||
| and percutaneous suturing for closing | ||
| incision sites. | The WECK EFx Endo Fascial Closure | |
| System has application in laparoscopic | ||
| procedures for approximation of tissue | ||
| and percutaneous suturing for closing | ||
| incision sites. | ||
| 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 10-15mm | ||
| trocar port site | ||
| -Suture Passer is introduced into | ||
| abdominopelvic cavity by insertion | Same | |
| Compatibility | ||
| Other Devices | Trocar: 10~ 15 mm | 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 | |
| Differences | ||
| Sterilization | ||
| Method | Ethylene Oxide sterilization, 10-6 SAL | Radiation, 10-6 SAL |
7. Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specification for its intended use. The following tests were performed on the device.
Sterilization validation
Sterilization validation was conducted in accordance with ISO 11135:2014 "Sterilization of health-care products-Ethylene oxide -Requirement for the development, validation and
6
routine control of a sterilization process for medical devices". Sterilization has been validated to achieve a Sterility Assurance Level (SAL) of 10-6.
Mechanical testing
Abclose - Port Site Closure Device's mechanical function and structure integrity were tested to demonstrate that the design specification from design input are fulfilled. Mechanical safety test were also conducted to demonstrate the insertion portion of the device remain intact during the surgery and raise no safety concern.
Animal test
The intended use has been conducted by animal test to demonstrate the AbClose - Port Site Closure Device can deliver the intended function of application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
8. Conclusion
Base on the intended use and/ or indications for use, technological characteristics, performance testing and comparison to predicate device, the AbClose - Port Site Closure Device is substantially equivalent to the predicate device.