(146 days)
Not Found
No
The device description focuses on mechanical components and functions for suturing. There is no mention of AI, ML, or any computational processing of data for decision-making or analysis.
No
This device is described as a surgical tool used for suturing soft tissue during gastroenterological procedures, not for treating or diagnosing a disease or condition itself. It's an instrument used to facilitate a surgical act.
No
Explanation: The device description clearly states its purpose is to suture soft tissue during gastroenterological procedures, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components (concentric tubes, wire, needle, loop, holder, knot pusher) and their mechanical functions for suturing, indicating it is a hardware 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 "suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope." This describes a surgical procedure performed directly on a patient's tissue in vivo.
- Device Description: The device is a mechanical system designed to manipulate sutures and tissue in vivo. It does not involve the examination of specimens (like blood, urine, or tissue samples) in vitro to provide diagnostic information.
- Lack of Diagnostic Purpose: The device's function is to repair tissue, not to diagnose a disease or condition.
IVD devices are used to examine specimens outside of the body to provide information for the diagnosis, treatment, or prevention of disease. This device operates inside the body to perform a therapeutic action (suturing).
N/A
Intended Use / Indications for Use
The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
Product codes
OCW
Device Description
The PARÉ Endoscopic Suturing System consists of three concentric tubes and a wire that can fit down the operating channel of a flexible endoscope. Each of the concentric tubes controls a function that is required to do soft tissue suturing at the distal end of the endoscope. These functions include:
- A needle, which is used to puncture through the soft tissue 1.
-
- A loop, which is used to capture the free end of the suture.
-
- A holder for the suture that is formed into a pre-tied knot.
- A knot pusher, which also performs the function of cutting the suture once the knot is positioned and formed.
The device will be loaded only with sutures that have received FDA approval for human use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, gastroenterological procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical physician
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)
Bench test results using fresh swine esophagus, stomach and colon soft tissue showed that the materials chosen to be utilized in the PARE Endoscopic Suturing System meet the established specifications necessary for consistent performance of its intended use. The device was invitro tested six times using the operating channel of an Olympus Colonoscope type CF-1T140 and six times using an Olympus Gastroscope type GIF-PQ20. In all experiments the device was able suture the soft tissue including the dropping of the pre-tied knot.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
2 7 2015 .JUL -
Pare Surgical, Inc. Mr. Richard P. Fleenor President 7332 S. Alton Way, Unit H Englewood, Colorado 80112
Re: K003102
Trade/Device Name: PARE Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): December 27, 2000 Received (Date on orig SE ltr): December 28, 2000
Dear Mr. Fleenor,
This letter corrects our substantially equivalent letter of February 27, 2001.
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
1
Page 2 -
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); 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 Small Manufacturers. International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance 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,
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication For Use
510(k) Number : K003102
Device Name: PARÉ Endoscopic Suturing System
Indication For Use: The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X Use___ (Per 21 CFR 801.109) OR
Over -The Counter
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K003102
3
INNOVATIVE MEDICAL DEVICES
PARÉ SURGICAL, INC. 7332 S. Alton Way, Unit H Englewood, CO 80112
K003102
Phone: 303.689.0187
Fax: 303.689.0579
PARE
FEB 2 7 2001
510(k) Summary
As required under Section 513(i)(3)(A) of the Safe Medical Device Act of 1990, an adequate summery of any information respecting the safety and effectiveness follows:
A. General Information:
Name and address of submitter:
Contact:
Date of summery:
Name of device:
Common name:
Classification:
PARÉ Surgical, Inc. 7332 S. Alton Way, Suite H Englewood, CO 80112
Richard Fleenor President Phone: 303.689.0187 Fax: 303.689.0579
December 27, 2000
PARE Endoscopic Suturing System
Endoscopic Suturing Device
78KOG- Endoscopic Suturing Device
B. Predicate Devices:
Company
- PARÉ Surgical, Inc.
Trade Name
Quik-Stitch™
System
510(k) Number
K953123 Endoscopic Suturing
- BARD
Bard Endoscipic Suturing K994290 System
2 ·
4
C. Description:
The PARÉ Endoscopic Suturing System consists of three concentric tubes and a wire that can fit down the operating channel of a flexible endoscope. Each of the concentric tubes controls a function that is required to do soft tissue suturing at the distal end of the endoscope. These functions include:
- A needle, which is used to puncture through the soft tissue 1.
-
- A loop, which is used to capture the free end of the suture.
-
- A holder for the suture that is formed into a pre-tied knot.
- A knot pusher, which also performs the function of cutting the suture once র্ব the knot is positioned and formed.
The device will be loaded only with sutures that have received FDA approval for human use.
D. Intended Use:
The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
E. Technological Characteristics Summary:
The technological characteristics of the PARÉ Endoscopic Suturing System is the same or similar to the predicate devices in that the materials used to manufacture these products are the same type of medical grade stainless steels and plastics. The products all share common features such as material types provide a means for driving a needle through soft tissue and capturing the suture in the distal side. They all suture soft tissue by manually actuating the needle with a handle mechanism. They all are designed to allow reloading of suture to deliver multiple stitches under endoscopic visualization. Further, the PARÉ Endoscopic Suturing System and the predicated devices have the same of similar intended use, that is too place stitches and tie suture material to approximate soft tissue under endoscopic visualization.
3
5
F. Performance Data:
Bench test results using fresh swine esophagus, stomach and colon soft tissue showed that the materials chosen to be utilized in the PARE Endoscopic Suturing System meet the established specifications necessary for consistent performance of its intended use. The device was invitro tested six times using the operating channel of an Olympus Colonoscope type CF-1T140 and six times using an Olympus Gastroscope type GIF-PQ20. In all experiments the device was able suture the soft tissue including the dropping of the pre-tied knot.
510(k) Number : K003102
Device Name: PARE Endoscopic Suturing System
Indication For Use: The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X Use___ (Per 21 CFR 801.109) OR
Over -The Counter