(144 days)
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.
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.
The provided text describes a 510(k) summary for the Electrocautery Dilation Balloon. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific performance metrics akin to a novel AI device.
Therefore, many of the typical "acceptance criteria" and "study" details requested for an AI device (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, and types of ground truth) are not applicable to this traditional medical device submission.
Here's a breakdown based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission focuses on "Product testing" to ensure the device performs as intended and is safe. The acceptance criteria are largely based on engineering performance specifications rather than clinical accuracy for diagnostic or prognostic purposes, which would involve concepts like sensitivity, specificity, etc.
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Functional Performance | Inflation/Deflation/Burst integrity | Met specification |
| Mechanical Performance | Atraumatic tip | Met specification |
| Electrocautery Function | Electrocautery extension/retraction | Met specification |
| Material Durability | Corrosion resistance | Met specification |
| Overall Equivalence | Equivalent to predicate devices in: | Substantially equivalent |
| - Indications for use | ||
| - Basic overall function | ||
| - Methods of manufacturing | ||
| - Materials used |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission does not describe a clinical "test set" in the context of evaluating diagnostic accuracy or a similar performance claim requiring patient data. The testing mentioned (
inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing) refers to bench testing of the device itself, likely using a sample of manufactured devices, but the specific number is not provided. Data provenance (country of origin, retrospective/prospective) is also not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. There is no "ground truth" to establish in the context of diagnostic performance for this type of device submission. The device is a tool for a medical procedure, and its performance is assessed against engineering and functional specifications, not against a diagnostic gold standard in patient cases.
4. Adjudication Method for the Test Set:
- Not Applicable. As there's no clinical test set requiring expert interpretation or labeling, there's no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. An MRMC study is relevant for evaluating the clinical impact of an AI diagnostic aid on human readers. This device is a surgical/interventional tool, not an AI diagnostic system, so such a study would not be performed for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical instrument, not an algorithm. Standalone performance as typically described for AI devices is irrelevant.
7. The Type of Ground Truth Used:
- Not Applicable (in the AI/diagnostic sense). The "ground truth" for this device's performance would be engineering specifications and functional requirements (e.g., "the balloon must inflate to X pressure without bursting," "the knife must extend and retract smoothly"). These are verified through direct measurement and observation during bench testing.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there's no training set, this question is not relevant.
In summary: The provided 510(k) pertains to a traditional device (electrocautery dilation balloon) demonstrating substantial equivalence to predicates through bench testing and material compatibility. The performance criteria are therefore engineering and functional, not clinical diagnostic accuracy, which is why many of the requested AI-centric details are not present in the document.
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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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K082114
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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
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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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§ 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).