(144 days)
Not Found
No
The summary describes a mechanical and electrosurgical device with no mention of AI or ML capabilities.
Yes
The device is intended for "dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures," which are therapeutic interventions.
No
The device is described as being used for "dilation of strictures" and "cutting, dissecting and cauterizing soft tissue," which are interventional and therapeutic procedures, not diagnostic ones.
No
The device description clearly details a physical balloon and needle knife, which are hardware components used for dilation, cutting, dissecting, and cauterizing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Electrocautery Dilation Balloon is used directly within the patient's body (in vivo) for a therapeutic purpose (dilation of strictures and cutting/cauterizing tissue). It does not analyze specimens taken from the body.
The description clearly indicates the device is used for a surgical procedure performed inside the patient.
N/A
Intended Use / Indications for Use
The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
Product codes
KNS
Device Description
The Electrocautery Dilation Balloon is indicated for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Using either endoscopic or fluoroscopic means, the balloon is placed at the physician selected site. Once in place, the clinician inflates the balloon to dilate the stricture. The electrocautery needle knife may be used for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The needle knife is advanced and retracted with the proximal handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic
Anatomical Site
esophagus and gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
Product testing was completed and met specification. Testing includes inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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K082114
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510(k) Summary
DEC 1 9 2008
General Information
Classification
Submitter
Trade Name
Electrocautery Dilation Balloon
Apollo Endosurgery, Inc. 7000 Bee Caves Road Suite 350 Austin, Texas 78746
Class II
Tel: (512) 328-9990
Contact
Dennis Mc Williams President & CEO
Intended Use
The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
Predicate Devices
| K993720 | Cordis Maxi LD Dilation Balloon | Cordis |
|---|---|---|
| K023907 | Cordis Maxi LD Dilation Balloon | Cordis |
| K073046 | Endo Surgery Needle Knife | Ethicon |
Device Description
The Electrocautery Dilation Balloon is indicated for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Using either endoscopic or fluoroscopic means, the balloon is placed at the physician selected site. Once in place, the clinician inflates the balloon to dilate the stricture.
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The electrocautery needle knife may be used for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The needle knife is advanced and retracted with the proximal handle.
Materials
All materials used in the manufacture of the Electrocautery Dilation Balloon are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was completed and met specification. Testing includes inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing.
Summary of Substantial Equivalence
The Electrocautery Dilation Balloon is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2008
Mr. Gregory Mathison Vice President Regulatory Affairs Apollo Endosurgery, Inc. 7000 Bee Caves Road, Suite 350 AUSTIN TX 78746
Re: K082114
Trade/Device Name: Electrocautery Dilation Balloon Regulation Number: 21CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: December 12, 2008 Received: December 17, 2008
Dear Mr. Mathison:
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 such 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.
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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 complive th all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K082114
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Indications for Use
12114
510(k) Number (if known):
Device Name:
Electrocautery Dilation Balloon
Indications for Use:
The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hules Rem
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 082114 510(k) Number .
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