(26 days)
The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator 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 Dilator to allow for visualization at the stricture site.
The provided 510(k) summary (K093236) concerns the Ethicon Endo Surgery® Optical Dilator, a device indicated for the dilation of esophageal strictures under endoscopic visualization. This submission is a Special 510(k) as it details modifications to an existing predicate device (Ethicon Endo-Surgery Optical DVS Esophageal Dilator K031147). The changes are limited to the addition of a handle retainer component to secure the handle to the shaft and a change in the handle material from gray to black.
Given these minor modifications and the nature of the device, the studies conducted focus on verifying the safety and functionality of these specific changes rather than a comprehensive clinical study assessing the device's diagnostic or interventional efficacy in a clinical setting.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Attachment Strength of Handle/Retainer to Shaft | Test results demonstrate compliance; all criteria for success were met. |
| Biocompatibility for New Handle and Handle Retainer Materials | Test results demonstrate compliance with ISO 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for either the attachment strength or biocompatibility testing. These are typically bench tests performed on a representative number of units or material samples.
- Data Provenance: Not explicitly stated but implied to be from bench testing at the manufacturer's facilities. This is not clinical data, so country of origin and retrospective/prospective distinctions are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not Applicable. The ground truth for bench tests (attachment strength and biocompatibility) is established by predefined engineering specifications and international standards (ISO 10993-1). There is no need for expert clinical consensus for these types of tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessments. Bench testing results are typically evaluated against objective, predefined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-guided devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The modifications to this esophageal dilator do not involve AI or human interpretation in its use.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study was not done. This type of study is relevant for AI-powered devices to assess the algorithm's performance independent of human interaction. The Ethicon Endo Surgery® Optical Dilator is a mechanical medical device, not an AI or algorithm-driven system.
7. Type of Ground Truth Used
- For Attachment Strength: Engineering specifications and design requirements (e.g., a minimum force required to detach the handle).
- For Biocompatibility: International standard ISO 10993-1, which outlines biological evaluation of medical devices.
8. Sample Size for the Training Set
- Not Applicable. This device is hardware; there is no AI algorithm to be trained, therefore no training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.
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093236
pg 1 of 2
510(k) Summary
| Company | Ethicon Endo-Surgery, Inc. |
|---|---|
| 4545 Creek Road | |
| Cincinnati, OH 45242 |
- Renee Rowe Contact Staff QS/RA Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-8243 Fax: (513) 337-2243 Email: rrowe1@its.jnj.com
Date Prepared: October 16, 2009
New Device Name
Trade Name: Ethicon Endo Surgery® Optical Dilator
Common or Usual Name: Esophageal Dilator
Classification Name: Esophageal Dilator
Predicate Devices
Ethicon Endo-Surgery Optical DVS (Dual Vector Shearing) Esophageal Dilator (K031147)
Device Description
The device description is the same as that for the predicate device. The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator 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 Dilator to allow for visualization at the stricture site.
Indications for Use
The intended use is the same as that for the predicate device. The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
Technological Characteristics
The Ethicon Endo-Surgery Optical Dilator has the same technological characteristics, design, and intended use as the predicate device. The only difference between the new device and the predicate device is that a handle retainer component has been added to secure the handle to the shaft, and the handle material was changed from gray to black. Risk analysis (Failure Mode and Effects and Hazard Analysis) and engineering analyses were used to assess the impact of the modifications.
NOV 1 0 2009
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093236
pg 2 of 2
Performance Data
Bench testing was completed to verify the attachment strength of the handle retainer/handle to the shaft. And, biocompatibility testing was conducted for the new handle and handle retainer materials in accordance with the requirements of ISO 10993-1 and FDA General Program Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." Test results demonstrate compliance with ISO 10993-1. A declaration of conformity with Design Controls is included in this submission as required for a Special 510(k). All criteria for success were met.
Risk analysis, engineering analysis, design verification of the attachment strength of the new handle retainer / handle to the shaft, and biocompatibility testing of the new materials indicate that neither the addition of the handle retainer nor the change in the handle material has an impact on the functionality of the device. The fundamental scientific technology and the intended use are the same.
EES believes the new devices are safe and effective and substantially equivalent to the predicate device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Renee Rowe Staff Project Manager, QS/RA Ethicon Endo-Surgery, Inc. a Johnson & Johnson Co. 4545 Creek Road CINCINNATI OH 45242
NOV 1 0 2009
Re: K093236
Trade/Device Name: Ethicon Endo Surgery® Optical Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: October 14, 2009 Received: October 15, 2009
Dear Ms. Rowe:
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.
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 (reporting of medical
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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 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
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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Indications for Use
510(k) Number (if known): K093236
Ethicon Endo Surgery® Optical Dilator Device Name:
Indications for Use: The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
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)
Page 1 of 1 (Posted November 13, 2003)
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.