(42 days)
The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger.
The Endoscopic Applicator device is a sterile single use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. The Endoscopic Applicator consists of two components; (1) a minimally reflective stainless steel cannula and (2) a plastic stylet (obturator). The Endoscopic Applicator is designed with a luer connector, for connection to a syringe containing the hemostatic agent. The packaging used for the Endoscopic Applicator is a pouch that consists of a see-through laminated film and TYVEK. Alternatively, a second pouch may be used. Either package configuration is placed within a paperboard carton.
The provided text does not contain information about acceptance criteria or a study proving that an Endoscopic Applicator device meets acceptance criteria.
Instead, the document is a 510(k) summary for a medical device (Endoscopic Applicator) seeking substantial equivalence to a predicate device. It explicitly states that "performance testing was considered unnecessary" and "clinical data was deemed unnecessary to demonstrate equivalence of the new device to the predicate device for its intended purpose."
Therefore, I cannot provide the requested information based on the given text.
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AUG 9 - 2005
Rige 18
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
- Information supporting claims of substantial equivalence, 510(k) Summary of as defined under the Federal Food, Drug and Cosmetic Safety and Effectiveness as define safety and effectiveness is summarized Act, resposuring convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule 15 1010(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence 007) anyone requesting it from the Agency. NEW DEVICE NAME: Endoscopic Applicator PREDICATE DEVICE NAME: Endoscopic Applicator 510(k) SUMMARY The Endoscopic Applicator device is a sterile single use, Device Description disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. The Endoscopic Applicator consists of two components; (1) a minimally reflective stainless steel connula and (2) a plastic stylet (obturator). The Endoscopic Applicator is designed with a luer connector, for connection to a syringe containing the hemostatic agent. The packaging used for the Endoscopic Applicator is a pouch that consists of a see-through laminated film and TYVEK. Alternatively, a second pouch may be used. Either package configuration is placed within a paperboard carton. The Endoscopic Applicator is intended for use in delivering Intended Use hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. Continued on next page
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Kor1732
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
| Indications Statement | The Endoscopic Applicator is indicated for use in deliveringhemostatic agents to bleeding surgical sites through a 5mmtrocar or larger. |
|---|---|
| TechnologicalCharacteristics | The technological characteristics of the new device are thesame as the predicate device in that they both consist of acannula and a stylet that is used to deliver hemostaticagents to bleeding sites through a 5mm trocar or larger. Thenew device is provided sterile, for single patient use and isdisposable. |
| Performance Data | The Endoscopic Applicator( New Device) and the predicatedevice have the same intended use. The new device issubstantially equivalent to the predicate device in intendeduse, technological characteristics, design, components andmaterials, therefore, performance testing was consideredunnecessary. Clinical data was deemed unnecessary todemonstrate equivalence of the new device to the predicatedevice for its intended purpose. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21CFR 807) and the information provided herein, weconclude that the new device is substantially equivalent tothe Predicate Device under the Federal Food, Drug, andCosmetic Act. |
| Contact | Peter M. CecchiniFellow, Regulatory AffairsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151 |
| Date | June 27, 2005 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces left and is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 9 - 2005
Mr. Peter M. Cecchini Fellow, Regulatory Affairs ETHICON, Inc. Route 22 West Somerville, New Jersey 08876
Re: K051732
Trade/Device Name: Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 27, 2005 Received: June 28, 2005
Dear Mr. Cecchini:
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.
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Page 2- Mr. Peter M. Cecchini
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and wyour he FDA finding of substantial equivalence of your device to a legally promance hotel results 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), please If you assno office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gotting to thernational 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,
Barbara Buchund
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
510(k) Number (if known):
Endoscopic Applicator Device Name:
Indications for Use:
The Endoscopic Applicator is intended for use in delivering I he Endoscopic Appreator is interior in interior in Smm trocar or larger.
(PLEASE DO NOT WRITE BALOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The Counter Use
(Pcr 21 CFR 801.109)
(Optional Format 1-2-9G)
Caroline Buechler for MCM
Vision Sign 1 " storativ Division and New
5108, : tor K051732
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§ 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.