(165 days)
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, and colonoscope.
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).
The provided text is a 510(k) premarket notification letter from the FDA regarding the OBP Self-Sealing Endoscopic Seal. It determines the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the format requested. It describes the device, its intended use, classification, and regulatory information, but lacks detailed performance data, study methodologies, or expert validation information.
Therefore, I cannot fulfill the request for information regarding:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This type of detailed performance data and study information would typically be found in the full 510(k) submission, which is more extensive than this summary letter. The letter confirms substantial equivalence but does not present the underlying data from performance tests.
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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
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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 (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
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
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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
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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).
§ 884.1690 Hysteroscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.