(113 days)
Unknown
Unknown
No
The device description and performance studies focus on the mechanical function and sterilization of a simple adapter, with no mention of AI/ML or related concepts like image processing, data sets, or performance metrics associated with AI/ML algorithms.
No
Explanation: The device is described as an adapter for introducing tools/fluid through an endoscope's working channel, and its function involves facilitating this introduction. It does not directly treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
No
This device is described as an adapter for introducing tools and irrigation fluid through an endoscope. Its function is purely mechanical assistance, not to acquire, process, or interpret data about a patient's health condition to aid in diagnosis.
No
The device description clearly states it is a "one-piece metal construct" with physical components (luer fitting, tubular opening) and is intended for physical interaction (insertion into an endoscope working channel). It also mentions sterilization, which is a process applied to physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "For use as an adapter for the introduction of tools and/or irrigation fluid through the endoscope working channel." This describes a device used during a medical procedure to facilitate the use of other instruments and fluids within the body.
- Device Description: The description details a physical adapter with a luer fitting and a tubular opening, designed to connect to an irrigation source and be inserted into an endoscope. This is a mechanical device used for delivery and access.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing, analysis of samples, or diagnostic purposes.
- Performance Studies: The performance data mentioned relates to cleaning and sterilization validations, which are typical for reusable surgical or procedural instruments, not IVDs.
Therefore, the N.M. Beale Co., Inc. Scope Introducer is a procedural accessory used in conjunction with an endoscope, not a device for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
For use as an adapter for the introduction of tools and/or irrigation fluid through the endoscope working channel.
Product codes
KOG, ODC
Device Description
The N.M. Beale Co., Inc. Scope Introducer consists of a one-piece metal construct with a luer fitting on one end and a tubular opening at the other end. The luer connector of the introducer can be connected to an irrigation source; the tubular end is inserted into the endoscope working channel to facilitate the introduction of accessories and/or irrigation. The Scope Introducer can be reused and is intended to be sterilized between uses.
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)
Performance data provided in this submission consists of cleaning and sterilization validations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Unknown
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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N.M. Beale Co., Inc. October 7, 2009
FEB 1 6 2010
Image /page/0/Picture/2 description: The image contains a sequence of handwritten digits. The digits appear to be '1093325'. The numbers are written in a cursive style, with some connections between the digits. The image is in black and white.
ត្រូវ
Section 5 - 510(k) Summary
General Information
Owner's Name: Address:
Telephone Number: Contact Person:
Trade Name:
N.M. Beale Co., Inc. P.O. Box 494 Harvard, MA 01451 (800) 989-9558 Nathaniel Beale, President
Subject Device: Scope Introducer Classification/Regulation: KOG - Endoscope and/or accessories 21 CFR 876.1500: Class II
Predicate Devices:
Trade Name: Classification/Regulation:
Scope Introducer (Hobbs Medical, Inc) KOG - Endoscope and/or accessories 21 CFR 876.1500; Class II Unknown ·
Premarket Notification: .
Device Description
The N.M. Beale Co., Inc. Scope Introducer consists of a one-piece metal construct with a luer fitting on one end and a tubular opening at the other end. The luer connector of the introducer can be connected to an irrigation source; the tubular end is inserted into the endoscope working channel to facilitate the introduction of accessories and/or irrigation. The Scope Introducer can be reused and is intended to be sterilized between uses.
Indications for Use
For use as an adapter for the introduction of tools and/or irrigation fluid through the endoscope working channel.
Performance Testing
Performance data provided in this submission consists of cleaning and sterilization validations.
Conclusion
The N.M. Beale Co., Inc. Scope Introducer is substantially equivalent to the predicate device
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
FEB 1 6 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
N.M. Beale Co., Inc. % Ms. Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K093329
Trade/Device Name: Scope Introducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: October 7, 2009 Received: November 30, 2009
Dear Ms. Papineau:
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 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 of medical device-related
2
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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N.M. Beale Co., Inc. October 7, 2009
Section 4 - Indications for Use Statement
510(k) Number (if known):
K093329
Device Name: Scope Introducer .
Indications for Use:
For use as an adapter for the introduction of tools and/or irrigation fluid through the endoscope working channel.
Prescription Use X . (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Per 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)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
01 0014