(321 days)
Not Found
No
The device description and performance studies focus on mechanical components and physical properties, with no mention of AI/ML, image processing, or data analysis.
No.
The device is used for soft tissue or prosthetic material approximation during surgical procedures, which is a supportive function rather than directly treating a disease or condition to restore health.
No
The device, neoClose® PDS, is indicated for the approximation of soft tissue or prosthetic material during surgical procedures. It is a surgical tool used for physically joining tissues, not for identifying a disease, condition, or health status.
No
The device description explicitly states it consists of physical components: absorbable PDS Anchors and neoClose Drivers, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures." This describes a surgical device used directly on a patient's body during a procedure.
- Device Description: The description details absorbable anchors and drivers used to physically manipulate tissue. This is consistent with a surgical implant or fixation device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's health status. IVDs are designed for this type of analysis.
Therefore, the neoClose® PDS device falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The neoClose PDS device consists of absorbable PDS Anchors and neoClose Drivers. The PDS Anchor consists of an absorbable PDS suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose PDS Anchor x 2 (NCPDSX2-U) and the neoClose PDS Anchor x 4 (NCPDSX4-U). The neoClose PDS Anchors and Drivers are provided sterile (EtO).
The neoClose PDS Anchors are pre-loaded on neoClose Drivers, which are passed through soft tissue for subsequent soft tissue or prosthetic material approximation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue or prosthetic material (during open or laparoscopic surgical procedures)
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)
In Vitro and Ex Vivo testing were completed.
Results of testing have demonstrated that no adverse effects were introduced and the physical properties are appropriate for the intended use.
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
November 8, 2018
neoSurgical Ltd % Ms. Orla Brennan Ouality Assurance & Regulatory Affairs Director Block 12 Galway Technology Park Parkmore Galway, H91 E4YD Ireland
Re: K173917
Trade/Device Name: neoClose PDS Anchor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 26, 2018 Received: October 9, 2018
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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173917
Device Name neoClose PDS Anchor
Indications for Use (Describe)
neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.
Type of Use (Select one or both, as applicable):
| ☒ Registration Use (Part 21 CFR 201.3 Subject to) |
|---|
| □ Over-The-Counter Use (21 CFR 201.3 Subject to) |
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 For neoClose PDS Anchor
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the neoClose PDS Anchor
510(k) Number K173917
- l. SUBMITTER
neoSurgical Ltd. Block 12 Galway Technology Park, Parkmore, Galway, Ireland
Phone: +353 (0)91 421 000
Contact Person: Orla Brennan Date Prepared: 01 December 2017
- ll. DEVICE
Name of Device: neoClose PDS Anchor Common or Usual Name: Suture Passer Classification Name: Endoscope and Accessories (21 CRF 876.1500) Requlatory Class: II Product Code: GCJ
|||. PREDICATE DEVICE
IV. DEVICE DESCRIPTION
The neoClose PDS device consists of absorbable PDS Anchors and neoClose Drivers. The PDS Anchor consists of an absorbable PDS suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose PDS Anchor x 2 (NCPDSX2-U) and the neoClose PDS Anchor x 4 (NCPDSX4-U). The neoClose PDS Anchors and Drivers are provided sterile (EtO).
The neoClose PDS Anchors are pre-loaded on neoClose Drivers, which are passed through soft tissue for subsequent soft tissue or prosthetic material approximation.
4
V. INDICATIONS FOR USE
neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surqical procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate devices are based on the following technological elements:
- . Anchors are delivered into the abdominal cavity using a delivery device, and the sutures are tied to achieve approximation
- A delivery device is used to deliver the Anchor into the abdominal . cavitv
The following differences exist between the subject and predicate devices:
- A long-term absorbable suture has been introduced for the neoClose . PDS Anchor. All other materials are identical to the neoClose predicate.
VII. Support of Substantial Equivalence
neoSurqical has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the neoClose device is substantially equivalent to the currently marketed predicate devices. The neoClose device components have the same intended use as the predicate devices identified. Results of testing have demonstrated that no adverse effects were introduced and the physical properties are appropriate for the intended use. In Vitro and Ex Vivo testing were completed.
VIII. CONCLUSIONS
The neoClose PDS Anchor is substantially equivalent to the predicate devices. It has the same intended use and does not raise new questions reqarding safety or effectiveness. It is considered substantially equivalent in safety and effectiveness to the predicate device when used in accordance with the Instructions for Use.