(277 days)
Not Found
No
The summary describes a mechanical dilator and does not mention any software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is used for the dilation of esophageal strictures, which is a therapeutic intervention.
No
The device is described as an esophageal dilator used for treatment (dilation of strictures), not for identifying or diagnosing a condition. Its function is to expand the stricture, explicitly stating "to dilate esophageal strictures under endoscopic visualization," which is a therapeutic action.
No
The device description clearly states it is a physical, sterile, single-use, disposable esophageal dilator made from a flexible polymer, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Optical DVS Esophageal Dilator is a therapeutic device. Its purpose is to physically dilate (widen) a stricture (narrowing) in the esophagus. It is used in vivo (within the body) during an endoscopic procedure.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a tool used to perform a physical intervention.
The information provided clearly describes a medical device used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
Product codes (comma separated list FDA assigned to the subject device)
78 KNQ
Device Description
The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical DVS to allow for visualization at the stricture site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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)
Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator.
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.
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
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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JAN 1 2 2004
Page 1 of 1
Optical DVS (Dual Vector Shearing) Esophageal Dilator 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Kimberly Shoemaker Senior Regulatory Affairs Associate
Date Prepared:
April 8, 2003
Name of Device
Trade Name: Optical DVS (Dual Vector Shearing) Esophageal Dilator Classification Name: Esophageal Dilator
Predicate Devices:
Savary-Gilliard Dilators cleared under K851955 on 07/25/85
Device Description
The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical DVS to allow for visualization at the stricture site.
Indications for Use
The Ontical DVS is indicated for dilation of strictures of the esophagus under endoscopic visualization.
Technological Characteristics
The Optical DVS is similar to the predicate device with respect to design. The Optical DVS allows for visualization of strictures with the use of an endoscope where as the predicate device does not.
Performance Data
Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird, with a wavy line below representing the tail.
JAN 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kimberly Shoemaker Sr. Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. A Johnson & Johnson Co. 4545 Creek Road CINCINNATI OH 45242-2839
Re: K031147
Trade/Device Namc: OPTICAL DVS (Dual Vector Shearing) Esophageal Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: 78 KNQ Dated: October 13, 2003 Received: October 14, 2003
Dear Ms. Shoemaker:
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 usc 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 Fedcral 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.
If your device is classified (sec 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 Fedcral 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); good manufacturing practicc 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hantes of substantial equivalence of your device to a legally prematication. The PDF intems to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on increase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to premarked nonitode (21 cm 4ct may be obtained from the Division of Small information on your responsionalises and consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collection 115-11-11-11-11-11-11-11-11-11-11-11
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: OPTICAL DVS (Dual Vector Shearing) Esophageal Dilator
Indications for Use:
The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)