(62 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a reusable clip applier and disposable clips, with no mention of AI/ML terms or functionalities.
No.
The device is described as an instrument for surgical procedures (clip applier for ligating vessels), not a device intended to treat or cure a disease or medical condition.
No
The text describes a surgical instrument for occluding and ligating vessels and other tubular structures, not a device used for medical diagnosis.
No
The device description clearly details a physical, reusable instrument (Clip Applier) and disposable components (clip cartridge, titanium clips), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The device is a surgical instrument (clip applier) used to apply surgical clips. This is a physical manipulation of tissue within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical tool used for treatment during a procedure.
N/A
Intended Use / Indications for Use
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is intended for use to occlude vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures.
To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures
Product codes
FZP
Device Description
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, ducts, tracts, and other tubular structures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Applied Medical and Ethicon Endosurgery
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
JAN 0 8 2002
11. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
A. Submittor Information
Sponsor: Microline, Inc. C/o Interactive Consulting 70 Walnut Street Wellesley, MA 02481 Tel: 781 239-8108 Fax: 781 863-6488 Contact Person: Dr. Jean-Luc Boulnois Date Prepared: November 5, 2001
Manufacturer
Microline, Inc. 800-257-X Cummings Center Suite 157-X Beverly, MA 01915 Tel: 978 922-9810 Fax: 978 922-9209
Device Identification B.
Common/Usual Name: Laparoscopic Clip Cartridge with Implantable Titanium Clips Model ML-10
Classified Name: Implantable Clip (74FZP), 21 CFR 878.4300, Class II
- Applied Medical and Ethicon Endosurgery C. Identification of Predicate Device(s):
D. Device Description
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.
E. Intended Use
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is intended for use to occlude vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures.
F. Technolological Characteristics:
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips shares the same technological characteristics as the predicate devices in that they are comprised of similar design, materials, and intended use.
G. Conclusion of Substantial Equivalence
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips has the same intended use and the same basic technology as the predicates identified in the Premarket Notification Submission. The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips contain in some combination similar features, materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2002
Microline, Inc. c/o Ms. Jacqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02481
Re: K013695
Trade/Device Name: Microline Reusable Laparoscopic Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: November 05, 2001 Received: November 07, 2001
Dear Ms. Masse:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Ms. Jacqueline E. Masse
This letter will allow you to begin marketing your device as described in your Section 510(k) I market notification. The FDA finding of substantial equivalence of your device to a legally premits to dicated on "caresults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you declie 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R.P. Ogden for
Celia M. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known):
Kol 3695
Device Name:
Microline Reusable Laparoscopic Clip Applier with Single Use Titanium Clips Model M/L-10
Indications For Use:
To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NKO fr c mw
(Division Sign-Off) Division of Gene al, Restorative and Neurological Devices
2013695 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)