(59 days)
Not Found
Not Found
No
The summary describes a mechanical dilator and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as image processing and performance studies typically associated with AI/ML devices.
Yes
The device is used for "exploratory and dilation of strictures of the esophagus," which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as being used for "exploratory and dilation of strictures," which indicates a therapeutic or interventional purpose rather than diagnosis.
No
The device description explicitly lists physical components (silicone tip, stainless steel rod, nylon sleeve), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "exploratory and dilation of strictures of the esophagus." This is a direct intervention on the patient's body for a therapeutic purpose (dilation).
- Device Description: The device components (silicone tip, stainless steel rod, nylon sleeve) are physical tools designed for mechanical action within the esophagus.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a procedural intervention.
N/A
Intended Use / Indications for Use
To be used for exploration and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
Product codes
KNQ
Device Description
Device consists of silicone tip, stainless steel rod and nylon sleeve.
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)
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.
Jackson Esophageal Dilator made with Cyanoacrylate.
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.
0
K990935 p.1/1
MAY 17 1999
510(K) Summary
1. Submitter Name, Address, and Date of Submission.
Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034 Telephone Number
(800) 523-6507 (215) 643-7930 Fax
Contact: Same as above.
2. Name of the Device, Common, Proprietary (if known), and Classification.
Classification Name: Common Name: Proprietary Name: Class I Device
Esophageal Dilator Esophageal Dilator Jackson Esophageal Dilator
-
- Identification of the legally marketed device to which the submitter claims equivalence.
Jackson Esophageal Dilator made with Cyanoacrylate.
- Identification of the legally marketed device to which the submitter claims equivalence.
4. Description of the Device. Device consists of silicone tip, stainless steel rod and nylon sleeve.
5. Intended Use of the Device.
To be used for exploratory and dilation of strictures of the esophagus.
6. Summary of Technological Characteristics. The technological characteristics are the same as, or equivalent to the Jackson
Esophageal Dilator.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1999
Ms. Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, Pennsylvania 19034 Re: K990935 Jackson Esophageal Dilator Dated: March 17, 1999 Received: March 19, 1999 Regulatory Class: Il 21 CFR 876.5365/Procode: 78 KNQ
Dear Ms. Lazaro:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 the Electronic Product 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 questions on the promotion 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(K) Number (if known): K990935
Device Name: Jackson Esophageal Dilators
Indications for Use:
To be used for exploration and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-The-Counter Use _
(Per 21 CFR 801.1 09)
(Divisio
I
odominal, ENT,/
vices
510(K) Number
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990035