(165 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical seal for endoscopic working channels, with no mention of software, data processing, or AI/ML capabilities.
No.
The device's function is to prevent efflux of distention fluid during endoscopic procedures, acting as a seal for the endoscope working channel, which is a supportive role in a procedure rather than directly treating a disease or condition.
No
The device is described as an endoscopic seal that prevents fluid efflux during endoscopic procedures and does not indicate any function related to diagnosing a condition or disease.
No
The device description clearly indicates a physical, single-use, sterile endoscopic introducer seal with different size channels and colored bands, which are hardware components. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "endoscopic introducer seal" used to prevent fluid efflux during endoscopic procedures. This is a surgical/procedural device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its function as a seal for endoscope working channels. It describes physical characteristics and sizes, not components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Reagents or calibrators
Therefore, the OBP Self-Sealing Endoscopic Seal is a medical device used during endoscopic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
- cystoscope
colonoscope
Product codes (comma separated list FDA assigned to the subject device)
HIH, ODC, HET
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (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
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).