(37 days)
Not Found
No
The device description and performance studies focus on mechanical components and biocompatibility, with no mention of AI/ML or related concepts.
No
The device is used to facilitate the delivery of absorbable AutoAnchors through soft tissues during surgery for tissue approximation, which is a surgical tool rather than a therapeutic device that treats or cures a condition.
No
The device, neoClose, is described as facilitating the delivery of absorbable AutoAnchors for soft tissue approximation during surgery, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components (absorbable AutoAnchors, neoClose Drivers) and their function in delivering these anchors through tissue, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery." This describes a surgical tool used in vivo (within the body) for tissue approximation.
- Device Description: The description details a system of absorbable anchors and drivers used to deliver these anchors through tissue layers. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The neoClose device does not fit this description.
N/A
Intended Use / Indications for Use
neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The neoClose AutoAnchor Pack consists of absorbable AutoAnchors and neoClose Drivers. The neoClose AutoAnchor consists of an absorbable suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose 2 AutoAnchor Pack (NCAA2-U) and the neoClose 4 AutoAnchor Pack (NCAA4-U). The neoClose AutoAnchors and Drivers are provided sterile (EtO).
Each neoClose AutoAnchor is pre-loaded on a neoClose Driver. The neoClose Driver is used to deliver an AutoAnchor through the abdominal wall layers into the abdominal cavity for subsequent soft tissue approximation. The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues of the body, abdominal wall layers, abdominal cavity
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)
Biocompatibility: A biological evaluation was conducted for the neoClose AutoAnchor Pack in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The neoClose AutoAnchor is considered a permanent implant, while the neoClose Driver is considered tissue contacting for a duration that is less than 24 hours.
Bench Testing: Bench Testing was conducted for the neoClose AutoAnchor Pack to demonstrate that it is at least as safe and effective as the predicate device.
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.
neoClose Hasson and neoClose Universal (K123280; K131688)
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/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem depicts a stylized image of three faces in profile, layered on top of each other, suggesting a sense of community and interconnectedness. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
neoSurgical Ltd. Ms. Orla Brennan Quality Assurance/Regulatory Affairs Director Block 12 Galway Technology Park, Parkmore Galway, Ireland
Re: K142903
Trade/Device Name: neoClose Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 3, 2014 Received: October 6, 2014
Dear Ms. Brennan:
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/Resourcesfor You/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 yours,
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
2. Indications for Use Statement
510(k) Number:
Device Name:
neoClose
Indications for Use: neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.
Prescription Use__X_ (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
3. 510(k) Summary
510(k) Summary
l . SUBMITTER
neoSurgical Ltd. Block 12 Galway Technology Park, Parkmore, Galway, Ireland
Phone: +353 (0)91 421 000
Contact Person: Orla Brennan Date Prepared: October 3[d, 2014
ll. DEVICE
Name of Device: neoClose AutoAnchor Pack Common or Usual Name: Suture Passer Classification Name: Endoscope and Accessories (21 CRF 876.1500) Requlatory Class: II Product Code: GCJ
III. PREDICATE DEVICE
neoClose Hasson and neoClose Universal (K123280; K131688) This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The neoClose AutoAnchor Pack consists of absorbable AutoAnchors and neoClose Drivers. The neoClose AutoAnchor consists of an absorbable suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose 2 AutoAnchor Pack (NCAA2-U) and the neoClose 4 AutoAnchor Pack (NCAA4-U). The neoClose AutoAnchors and Drivers are provided sterile (EtO).
Each neoClose AutoAnchor is pre-loaded on a neoClose Driver. The neoClose Driver is used to deliver an AutoAnchor through the abdominal wall layers into the abdominal cavity for subsequent soft tissue approximation. The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide.
- V. INDICATIONS FOR USE
neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.
The Indications for Use statement for the neoClose AutoAnchor Pack is identical to the predicate device.
- VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject and predicate devices are used for the delivery of absorbable AutoAnchors into the abdominal cavity for subsequent soft tissue approximation. At a high level, the subject and predicate devices are based on the following same technological elements:
CONFIDENTIAL: DO NOT REPRODUCE WITHOUT PERMISSION FROM NEOSURGICAL
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- . Absorbable AutoAnchors are delivered into the abdominal cavity for subsequent approximation of tissue
- A neoClose Driver is used to deliver an AutoAnchor into the abdominal . cavity
- . The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide
The following differences exist between the subject and predicate devices:
- The modified neoClose Driver is stiffer than the predicate neoClose Driver ●
- The modified neoClose Driver has a revised tip design
- An alternative suture has been introduced for the neoClose AutoAnchor
- . The packaging has been modified
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
A biological evaluation was conducted for the neoClose AutoAnchor Pack in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA.
The neoClose AutoAnchor is considered a permanent implant, while the neoClose Driver is considered tissue contacting for a duration that is less than 24 hours.
Bench Testing
Bench Testing was conducted for the neoClose AutoAnchor Pack to demonstrate that it is at least as safe and effective as the predicate device.
VIII. CONCLUSIONS
The neoClose AutoAnchor Pack is considered substantially equivalent to the predicate device. It has the same intended use and does not raise new questions reqarding safety or effectiveness. It is considered at least as safe and effective as the predicate device when used in accordance with the Instructions for Use.