(30 days)
Not Found
Not Found
No
The summary describes a mechanical device (overtube) and its intended use and testing, with no mention of software, image processing, AI, or ML.
No
The device is described as an accessory used with an endoscope to facilitate repeated intubation during procedures like esophageal ligation or polyp removal. It does not actively treat or diagnose a disease or condition itself, but rather provides support during endoscopic procedures.
No
Explanation: The device description and intended use indicate that the Bard® Endoscopic Overtube is used to facilitate repeated endoscopic intubation. It is a tool for procedural support (e.g., esophageal ligation, polyp removal), not for identifying or characterizing a disease or condition. Its performance studies focus on physical properties (tensile performance, biocompatibility) rather than diagnostic accuracy metrics.
No
The device description explicitly states it consists of a "flange bonded to a plastic sheath," indicating it is a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used with an endoscope for procedures within the esophagus, such as ligation, polyp removal, and foreign body removal. This is a direct intervention and visualization tool, not a test performed on samples taken from the body.
- Device Description: The description details a physical device (flange, plastic sheath) inserted into the esophagus. This is consistent with a medical device used for access and protection during endoscopic procedures, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description 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 information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is to facilitate endoscopic procedures by providing a stable and protected pathway, which is a characteristic of a medical device used for intervention and access, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
To be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.
Product codes
78 KOG
Device Description
The Bard® Endoscopic Overtube consists of a flange bonded to a plastic sheath and is inserted into the esophagus through an initially placed bite block.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, hypopharynx, airway
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)
The Bard® Endoscopic Overtube has been subjected to nonclinical, tensile performance testing and biocompatibility testing. These tests conclude that this device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olympus Splinting Tube ST-C3
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.
0
K 97 3500
pg/cg 3
Bard Interventional Products Division
C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989
BAN
OCT 16 1997
510(k) Summary for the Bard® Endoscopic Overtube VI
As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (I)(3)(A) of the Act, an adequate summary of any information respecting safety and effectiveness follows.
- A. Submitter Information:
- Name and address of submitter: -Bard Interventional Products Division, C.R. Bard. Inc. 129 Concord Road, Building 3 Billerica, MA 01821
-Telephone (978) 663-8989 Fax (978) 262-4878
- Contact Person: -Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator
- Date of Preparation: -October 8, 1997
B. Device Name:
ﺖ
- Bard® Endoscopic Overtube Trade Name:
- Common/Usual Name: Overtube -
- Classification Name: Endoscope and accessories -(per 21 CFR 876.1500)
C. Predicate Device Name:
- Trade Name: Bard® Endoscopic Overtube --
- Trade Name: Olympus Splinting Tube ST-C3
1
K97 3500 pg 2 of 3
- D. Device Description:
- The Bard® Endoscopic Overtube consists of a flange bonded to a plastic sheath and is inserted into the esophagus through an initially placed bite block.
- E. Intended Use of Device:
- The Bard® Endoscopic Overtube is intended to be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.
- F. Technological Characteristics Summary:
- Both of the proposed and existing Bard® overtubes share a similar design consisting of a proximal cryolite flange, UV bonded to a polyvinyl chloride sheath with a distal tapered tip and is intended for use with an initially placed bite block. Both overtubes are indicated for twenty-five (25) reuses.
The proposed overtube also employs an encapsulated stainless steel tempered wire coiled along the length of its sheath and externally encapsulated within the polyvinyl chloride as does the Olympus Splinting Tube.
Similarities and Differences Summary:
- -Similarities
Both the proposed and existing Bard® overtubes share a similar design consisting of a proximal flange UV bonded to a sheath with a distal tapered tip and is intended for use with an initially placed bite block. Either device is designed to protect the hypopharynx from the trauma of repeated intubations, the airway from aspiration and the esophagus during extraction of sharp objects or foreign bodies. The labeled warnings and contraindications remain the same and both overtubes are indicated for twenty-five (25) reuses.
The proposed Bard® Endoscopic Overtube is similar in technological
2
K97 3500 Pg 3 of 3
characteristic as the Olympus, Splinting Tube ST-C3, with a wire coil along the length of its sheath that is encapsulated. Additionally, an overtube has a similar intended use as a splinting tube in aiding endoscope insertion through the tube to reach a target area and perform a specific function, while the surrounding anatomy is protected from potential trauma of endoscope reinsertion.
Differences
- The proposed Bard® Endoscopic Overtube will be somewhat longer and the distal tip will have a beveled rather than blunt taper. The sheath will include a frosted polyvinyl chloride for a lower friction surface and will have an encapsulated coil to maximize shaft ID for repeated intubations.
- ். Performance Data:
- The Bard® Endoscopic Overtube has been subjected to nonclinical, tensile performance testing and biocompatibility testing. These tests conclude that this device is safe and effective.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 1997
Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road Billerica, Massachusetts 01821-7031
Dear Ms. Gordon:
Re: K973500
Bard® Endoscopic Overtube Dated: September 15, 1997 Received: September 16, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 KOG
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, subject to the general controls provisions of 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.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K9Z3500____________________________________________________________________________________________________________________________________
____ Bard® Endoscopic Overtube________________________________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
To be used with an endoscope when repeated endoscopic intubation is anticipated,
of management of the l o be used with an endoscope when repeated chaosepts in the management of management of the foreign bodies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | Robert P. Saling |
|---|---|
| ------------------- | ------------------ |
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K973500 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ (Per 21 CFR 801.109) |
|---|---|
| OR | |
| Over-The-Counter Use | ________________ (Optional Format 1-2-96) |