ENDOMARK STERILE INDIA INK

K042901 · Pmt Corp. · NBG · Mar 16, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042901
• Device Name: ENDOMARK STERILE INDIA INK
• Applicant: Pmt Corp.
• Product Code: NBG · Gastroenterology, Urology
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

Device Story

Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink supplied in 10 mL single-use vials. It is used by endoscopists to perform endoscopic tattooing or marking of polyps and lesions within the gastrointestinal tract. The ink serves as a visual marker to assist surgeons in locating specific lesions during subsequent surgical removal procedures. The device is intended for use in clinical settings where endoscopic procedures are performed.

Clinical Evidence

Safety and effectiveness supported by chemical analysis, biocompatibility testing, and clinical experience.

Technological Characteristics

Sterile, non-pyrogenic India ink formulation; supplied in 10 mL single-use vials; intended for endoscopic delivery.

Indications for Use

Indicated for patients undergoing endoscopic procedures in the GI tract where the endoscopist anticipates the lesion will require surgical removal within thirty days.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Spot Endoscopic Marker (K993951)

Submission Summary (Full Text)

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K042901
p1 of 2

## 510(k) Summary PMT Corporation Endomark™ Sterile India Ink

#### SPONSOR 1.

PMT Corporation 1500 Park Road Chanhassen, MN 55317

Eric Caille Contact : 952-470-0866 Phone:

Date Prepared: October 19, 2004

#### DEVICE NAME 2.

·

:

Endomark™ Sterile India Ink Proprietary Name: Common/Usual Name: Colon marker Classification Name: Colon marker

#### PREDICATE DEVICE 3.

- Spot Endoscopic Marker (K993951) .
#### DEVICE DESCRIPTION 4.

The Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in single-use 10 mL vials.

#### INTENDED USE ક.

The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

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### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ర.

The Endomark™ Sterile India Ink is substantially equivalent to the predicate The Endomark - Sterile India Ink and the predicate device 1ave conomiance. The Endomation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - endoscopically tattooing or marking the colon.

#### PERFORMANCE TESTING 7.

Information submitted in this premarket notification to support the safety and information backined in the free India Ink includes results of chemical analysis, biocompatibility testing, and clinical experience.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird in flight, with three curved lines representing its wings and body. The bird is facing to the left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2005

Mr. James R. Veale Vice President, Strategic and Technical Assistance Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K042901 Ro42901
Trade/Device Name: Endomark™ Sterile India Ink Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 NBG Dated: February 7, 2005 Received: February 8, 2005

Dear Mr. Veale:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced work 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 the enorological of 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 active, but to an go and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 I ou'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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This letter will allow you to begin marketing your device as described in your Section 510(k)
. In the success of the Career of a beterrial equivalence of your device to a This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA indine of substantial equivalence of you premarket notification. The FDA finding of substantial equiraletted or your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device on our labering regaration (1) - 1
contact the Office of Compliance at one of the following numbers, based on the regulation num the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your respectioners at its toll-free number (800) DIVISIOn of [phone] or at its Internet address 056-2041 or (3.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Endomark™ Sterile India Ink

Indications for Use:

The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the The Endomark™ Sterlie India ink is marcator 10 n will require surgical removal within
GI tract when the endoscopist anticipates the lesion will require surgical removal withi thirty days.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lavid de leperer.

(Division Sign-Off) (Division of Reproductive, Abdomin and Radiological Devices 51()(k) Number _