OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK

K091838 · Obp Medical · HIH · Dec 4, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091838
• Device Name: OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
• Applicant: Obp Medical
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparoscope, cystoscope, colonoscope.

Device Story

The OBP Self-Sealing Endoscopic Seal is a single-use, sterile accessory designed for attachment to the proximal port of an endoscope's working channel. It functions as a mechanical barrier to prevent the leakage (efflux) of distention fluids during endoscopic procedures, both when the channel is idle and when surgical instruments are being passed through it. The device is available in four distinct channel sizes (0.6mm, 1.2mm, 1.6mm, and 2.0mm), each color-coded for identification (yellow, light pink, green, and blue, respectively). It is intended for use by clinicians during endoscopic procedures involving hysteroscopes, laparoscopes, cystoscopes, or colonoscopes. By maintaining the integrity of the distention medium, the device facilitates clearer visualization and operational efficiency for the physician.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use, sterile endoscopic accessory. Features four channel sizes (0.6mm, 1.2mm, 1.6mm, 2.0mm) identified by color-coded bands. Mechanical seal design for attachment to endoscope proximal ports. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a single-use, sterile endoscopic introducer seal for hysteroscopes, laparoscopes, cystoscopes, and colonoscopes to prevent efflux of distention fluid during endoscopic procedures.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JUL 2 7 2015

Mr. Jason Swift Vice President of Operations OBP Medical 360 Merrimack Street, Bldg. #9 Lawrence. MA 01843

Re: K091838

> Trade/Device Name: OBP Self-Sealing Endoscopic Seal Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, ODC, HET Dated (Date on orig SE ltr): November 12, 2009 Received (Date on orig SE ltr): November 17, 2009

Dear Mr. Swift,

This letter corrects our substantially equivalent letter of December 4, 2009.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Benjamin 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}------------------------------------------------

## Indications for Use

510(k) Number (if known): K091838

Device Name: OBP Self-Sealing Endoscopic Seal

Indications For Use:

The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes:

hysteroscope ಂ

laparoscope o

- cystoscope 0
colonoscope o

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hale Semen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page 1 of 1

{3}------------------------------------------------

## 510k Summarv

## 510(k) Number (if known): K091838

DEC - 4 2009

Device Name: OBP Self-Sealing Endoscopic Seal

510k Summary:

Premarket Notification 510(k) Summary

Prepared By: .

Telephone Number: Fax Number:

Contact Persons:

Trade Name:

Classification Name:

Common Name:

Classification: Regulation Number:

Description of Device:

OBP Corporation

857-453-2492 866-636-2718

Dr. Keith Isaacson / Jason Swift

OBP Self Sealing Endoscopic Seal with Luer Lock

Hysteroscopic/Cystoscopic/Laparoscopic/Colonoscopic accessory Seal with Luer Lock

Class II 21 CFR 876.1500 and 884.1690

The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparascope, cystoscope, and colonoscope. The seal comes with 4 different size channels to accommodate different size instruments. They are: 0.6mm, 1.2mm, 1.6mm, and 2.0mm. The 4 different seals are marked with different colored bands: yellow (0.6mm seal), light pink (1.2mm seal), green (1.6mm seal), and blue (2.0mm seal).