(34 days)
The Canady Plasma Probes' intended use is for the delivery of argon gas plasma energy for argon enhanced coagulation of tissue.
The Canady Plasma Probes are tubular instruments and are flexible. They are provided in various lengths and diameter sizes to accommodate the various size/types of endoscopes for a variety of applications (i.e. the treatment of various target tissues inside a patient). The Probes have applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas.
The device consists of a connector which acts also as a handle for maneuvering the probe inside the working channel of an endoscope. Via an inner lumen of the Canady Plasma Probe argon gas is delivered to the operative site as well as an internal wire to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during coagulation procedure.
The provided text describes a 510(k) premarket notification for the Canady Plasma Probes for flexible Endoscopy, specifically the Canady Plasma GIT Probe and Canady Plasma TBS Probe. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested sections cannot be filled from the given text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance results from a study. It states that "Canady Plasma Probes are substantial equivalent in its Intended Use, Dimensions, Used Materials, Construction, Safety, Electrical Characteristics, and Operational Principles..." to predicate devices. This implies that the 'acceptance criteria' are met by demonstrating equivalence to established predicate devices rather than independent performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided. The document outlines a regulatory submission process based on substantial equivalence, not a clinical trial or performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth establishment is not described for a clinical or performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication is not 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. This device is an electrosurgical probe, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The applicant is asserting that their device is equivalent.
8. The sample size for the training set
Not applicable. This document is not describing an AI model development.
9. How the ground truth for the training set was established
Not applicable. This document is not describing an AI model development.
Summary based on the provided text:
The document is a 510(k) premarket notification for the Canady Plasma Probes for flexible Endoscopy. The primary method for gaining regulatory clearance is demonstrating substantial equivalence to already cleared predicate devices.
The "acceptance criteria" are implicitly met by comparing the device's characteristics to those of the predicate devices. The study proving this involves a direct comparison of:
- Intended Use: Argon enhanced coagulation of tissue.
- Dimensions: Lengths (1.6 m to 3.4 m), diameters (1.5 mm to 3.2 mm).
- Used Materials: Mentioned as "mantling" (may be a typo for "mantle" or similar) and Teflon.
- Construction: Tubular, flexible, connector/handle, inner lumen, internal wire, tungsten electrode tip, ceramic tip.
- Safety: Provided sterile by ethylene oxide, disposable (single use).
- Electrical Characteristics: Compatible with HF generators, max HF voltage and power specified (e.g., 4.0 kVp/50W for TBS; 4.3 kVp/90W for GIT 2.3mm; 4.3 kVp/120W for GIT 3.2mm).
- Operational Principles: Delivers argon gas and HF electrosurgical current for coagulation.
The "study" is the 510(k) submission itself, which details these comparisons. No specific clinical trial or analytical performance study with defined acceptance criteria and reported numerical performance metrics for the new device are described in this summary. The conclusion is that "The differences do not affect safety and effectiveness," thus proving the device meets the implicit acceptance criteria of being substantially equivalent to the predicate devices.
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Canady Plasma Probes for flexible Endoscopy 510(k) Premarket Notification
Submitted By:
Image /page/0/Picture/1 description: The image shows the logo for Canady Technology. The logo consists of a stylized eagle with the letters "CT" above it on the left. To the right of the eagle are the words "CANADY" in large, bold letters, with the word "TECHNOLOGY" underneath in smaller letters.
510(k) Summary
AUG 3 1 2005
510(k) Summary of Safety and Effectiveness for Canady Argon Plasma Probes
Canady Technology LLC
Page 1 of 2
| 24 Research DriveHampton, Virginia 23666 | ||
|---|---|---|
| Contact Person: | Dr. Jerome Canady757 857 4501Phone:757 855 7741Facsimile: | |
| Date Prepared: | 07.01.2005 | |
| Common Name: | Electrosurgical Argon Beam Probe | |
| Trade Name: | Canady Plasma Probes for flexible Endoscopv- Canady Plasma GIT Probe- Canady Plasma TBS Probe | |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories(21CFR878.4400) | |
| Product Code: | 79 GEI | |
| Predicate Devices: | - Erbe APC Applicators: K#963189, cleared Nov. 26, 1996- Erbe APC Applicators: K#013348, cleared Oct. 26, 2001- Conmed ABC Flex Probes: K# 990586, cleared May 17, 1999 |
Device Description:
The Canady Plasma Probes are tubular instruments and are flexible. They are provided in various lengths and diameter sizes to accommodate the various size/types of endoscopes for a variety of applications (i.e. the treatment of various target tissues inside a patient). The Probes have applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas.
The device consists of a connector which acts also as a handle for maneuvering the probe inside the working channel of an endoscope. Via an inner lumen of the Canady Plasma Probe argon gas is delivered to the operative site as well as an internal wire to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during coagulation procedure.
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Image /page/1/Picture/1 description: The image shows the logo for Canady Technology. The logo consists of a stylized bird on the left, with the letters "CT" above it. To the right of the bird is the word "CANADY" in large, bold letters, with the word "TECHNOLOGY" underneath in smaller letters. The logo is simple and professional, and the use of the bird suggests a sense of freedom and innovation.
510(k) Summary
The Canady Plasma Probes are provided sterile by means of ethylene oxide and are disposable (Single Use)
Application
Application
An endoscope is manipulated inside the patient to locate that requires treatment. Upon An enoscope is manipulated inside the policity to the working channel of the seans. The tinding the target tissue, the Canady Fridania Probe slightly protrudes from the end of the stages. The the endoscope, until the tip of the Probe ingmy provision of the area to be treated. The opening of the Probes have depth marker rings close to the tip for positioning purposes.
Canady Plasma Probes have depth marker rings close to the tip for positioning purpose Canady Plasma Probes have departmanter Rings of the proximity to tissue is close When high requency voltages redonos the series in the gas stream. This allows the enough, electrically conductive argon phone for current density upon arrival at the tissue current to now between the probe and the Reases coagulation. The application of the sunace from an AFD probe (Algori Platina Book), Inc. Canady Plasma Probes are for single use only.
Intended Use:
The Canady Plasma Probes' intended use is for the delivery of argon gas plasma energy for argon enhanced coagulation of tissue.
Electrical Characteristic:
Electrical Characteristic.
Canady Plasma Probes can be operated in combination with HF generators which are Carrady Plasma Prosos carred under K#013348 to a
max. HF voltage of 4.0 kVp / max. HF power of 50 W for the TBS probes
max. HF voltage of 4.3 kVp / max. HF power of 90 W for the GIT probes (2.3 mm)
max. HF voltage of 4.3 kVp / max. HF power of 120 W for the GIT probes (3.2 mm)
Dimensions:
Diffielistions:
The lengths of the Canady Argon Probes are 1.6 m (5.2 ft) to 3.4 m (11 ft). The diameters of the probes are 1.5 mm (4.5 Fr) to 3.2 mm (9.6 Fr).
Similarities to Predicate Devices:
Simmanties to I realeate Bornoon
The Canady Plasma Probes have the same performance specifications and intended use The Canady Tiasma Proooc navare also provided sterile by ethylene oxide and are like the predicate devices: They are are processible in function to the connector of disposables for single ase only. The see also compatible to the corresponding connector hose.
nose.
The tube diameters and lengths are very similar. Both, the Canady Plasma Probes and the The lube diameters and tengine and (scaled probe tip). Also the used predicate devices nave manang may the distal end and Teflon for the tubes of the probes - are identical. In consequence the insulation characteristic is the same. The electrical characteristics are one and the same.
Differences to Predicate Devices:
Differences to Predicate Devices K#990586 and K#963189 are different.
Conclusions:
Conclusions.
Canady Plasma Probes are substantial equivalent in its Intended Use, Dimensions, Used Canady Flashia Prodoc are See Electrical Characteristics, Operational Principles and Matehals, Construction, & Bally, Libbins to which the Canady Plasma Probes are compared in this submission.
The differences do not affect safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circle around the eagle. The seal is simple and monochromatic.
AUG 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Canady Technology, LLC c/o Mr. Stefan Preiss TPR Project Manager TUV America Inc., TUV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K052035
Trade/Device Name: Canady Plasma Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 17, 2005 Received: August 22, 2005
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaren as substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to conninered prox to May 20, 1978, as excordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). and Costine Act (71ct) that to nov request to the general controls provisions of the Act. The 1 ou may, morelore, manov of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 as controls. Existing major regulations affecting your device can inay be subject to sach additions, 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 r lease be advisou that I Drivistian that your device complies with other requirements of the Act that I DA has intace a and regulations administered by other Federal agencies. You must or any I edetar bander and eag...
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 practice requirements as set Of IT rate 6077, idoomig (21 CFR Part 820); and if applicable, the electronic forth in the quality Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Stefan Preiss
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin harketing your actives of your device of your device to a legally premarket notification. The PDA midning of substanted on the subsitive 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
rs of the may on any and 10, 2011 5 - All any desse not the regulation enti If you desire specific advice for your ac not on our s. Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the contact the Office of Compliance at (240) 276 - 1 - (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by reference to premarket nonfication" (1 s oct from the Division of Small other general information on your responsionnes ander at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number h Manufacturers, International and Consulter Prossent Prosses of cdrh/dsma/dsmamain.html
Sincerely vours,
Barbara Buehler
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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052035 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
______Canady Plasma Probe Device Name:
Indications for Use:
Argon Enhanced Coagulation of Tissue
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Please do not write below this line-continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehup for myxn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052035
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.