(175 days)
The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
The Aragon Surgical RF System consists of the Aragon Surgical Radiofrequency Energy (RF) Generator and a handheld Instrument, foot pedal, and power coad. The Aragon Surgical Instrument connects to the RF Generator. The Aragon Surgical Instrument is supplied sterile and is intended for single use. The Instrument uses a bipolar design, which means that a return pad is not required for operation. Software is utilized in the operation of the Aragon Surgical RF Generator.
The provided text describes the Aragon Surgical RF System and its 510(k) premarket notification (K081312) but does not contain information regarding specific acceptance criteria for performance metrics or a detailed study proving the device meets particular criteria, such as sensitivity, specificity, accuracy, or any comparative effectiveness data with human readers.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through bench and pre-clinical evaluations.
Here's an analysis based only on the provided text, outlining why certain sections of your request cannot be fulfilled:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The core of the 510(k) submission is to demonstrate substantial equivalence to predicate devices, not necessarily to meet specific, quantifiable performance criteria in a published table. | The document states "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical System is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria." However, specific performance metrics (e.g., burst pressure, thermal spread, sealing time) and their corresponding acceptance thresholds are not detailed. It mentions the ability to "seal vessels up to 7mm." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document mentions "bench and pre-clinical evaluations" but does not provide details on the number of samples, cases, or procedures involved.
- Data Provenance: Not specified. It only states "bench and pre-clinical evaluations." There is no mention of country of origin, or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe a study involving human experts establishing ground truth for a test set, as might be found in imaging or diagnostic device submissions. The evaluations mentioned are "bench and pre-clinical," implying laboratory and possibly animal studies.
4. Adjudication method for the test set:
- Not applicable/Not specified. As there's no mention of studies involving human readers or interpretation, no adjudication method would be detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. The document does not describe an MRMC comparative effectiveness study. This type of study is common for diagnostic imaging devices where human interpretation is a key component. The Aragon Surgical RF System is an electrosurgical device for tissue sealing and division.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a tool used by a surgeon. "Standalone performance" in this context would refer to the device's physical and functional capabilities (e.g., sealing strength, heat generation, division effectiveness). The document generally states that "bench and pre-clinical evaluations" were conducted to demonstrate it "meets design, safety, and effectiveness criteria." However, specific standalone performance metrics and results beyond "can seal vessels up to 7mm" are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "bench and pre-clinical evaluations," ground truth would likely be established through objective measurements (e.g., burst pressure testing for vessel seals, histological examination for tissue damage/seal integrity, temperature measurements) rather than expert consensus or pathology in the context of clinical expert interpretation.
8. The sample size for the training set:
- Not applicable/Not specified. The term "training set" typically refers to data used to train machine learning algorithms. While "Software is utilized in the operation of the Aragon Surgical RF Generator," the document does not describe the development of an AI algorithm based on a training set. The evaluations focus on the physical performance of the device itself.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no mention of a training set or AI algorithm development in the provided text.
Summary of Device and Performance Information Available from the Text:
- Device Name: Aragon Surgical RF System
- Indication for Use: Tissue sealing and division during abdominal hysterectomy, specifically sealing vessels up to 7mm.
- Demonstrated Equivalence: Substantially equivalent to predicate devices (LigaSure™ Vessel Sealing System K981916 and LigaSure™ Open Dissector Divider K041587) in terms of design, materials, principle of operation, and product specifications.
- Performance Data: "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical System is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria." The capability to "seal vessels up to 7mm" is explicitly mentioned.
- Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, justifying 510(k) clearance.
The document provided is a 510(k) summary focused on regulatory clearance via substantial equivalence, which often does not include the detailed performance study results that would be found in a peer-reviewed publication or a more comprehensive technical report.
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Aragon Surgical, Inc.
Aragon Surgical RF System Premarket Notification
KO 81312
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENE
REGULATORY AUTHORITY
OCT 3 1 200
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Alan Curtis Aragon Surgical, Inc. 1810 Embarcadero Road, Suite B Palo Alto, CA 94303
NAME OF DEVICE
| Trade Name: | Aragon Surgical RF System |
|---|---|
| Common Name: | Electrosurgical System |
| Device Product Code: | GEI |
| Classification Name: | Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400) |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |
PREDICATE DEVICES
DEVICE DESCRIPTION
The Aragon Surgical RF System consists of the Aragon Surgical Radiofrequency Energy (RF) Generator and a handheld Instrument, foot pedal, and power coad. The Aragon Surgical Instrument connects to the RF Generator. The Aragon Surgical Instrument is supplied sterile and is intended for single use. The Instrument uses a bipolar design, which means that a return pad is not required for operation.
Software is utilized in the operation of the Aragon Surgical RF Generator.
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Aragon Surgical, Inc.
Page 2 of ②
60098
INDICATION FOR USE STATEMENT
The Aragon Surgical System is indicated for tissue sealing and division during the performance of abdominal hysterectorny. The instrument can seal vessels up to 7mm.
This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
SUBSTANTIAL EQUIVALENCE COMPARISON
Comparison to Predicate Devices
The technological characteristics and indications for use of the Aragon Surgical System are similar to those of the cited predicate electrosurgical devices, as well as the similar RF Systems distributed by other manufacturers. These devices are equivalent in terms of design, materials, principal of operation, and product specifications. Any differences between the Aragon Surgical System and the predicate devices do not raise new issues regarding safety or effectiveness.
PERFORMANCE DATA
Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical System is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria.
CONCLUSION
Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. Sufficient data were obtained to demonstrate that the device is substantially equivalent to the predicate devices and raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2008
THE SEAT THE FOR FREE WANT SELL WAS THE WE WARE THE SECTION CAN BE COLLECT CARACT
Aragon Surgical % Mr. Alan Curtis, RAC VP, Regulatory/Clinical & Quality Affairs 1810 Embarcadero Road, Suite B Palo Alto, California 94303
Re: K081312
Trade/Device Name: Aragon Surgical Radiofrequency (RF) System and accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 10, 2008 Received: October 14, 2008
Dear Mr. Curtis:
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.
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); good manufacturing practice requirements as set
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Page 2 - Mr. Alan Curtis, RAC
いたいときなくてきた時間には出来ました。
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.
のためのないですけど、その後には出になるということです。そのままあると、そうなイイ・
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 Biometric's (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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Aragon Surgical Inc.
School States of the state of the starter of the states
Aragon Surgical RF System Premarket Notification
のことです。 このとてもなくなると、
SECTION 4
INDICATIONS FOR USE STATEMENT
510(k) Number:
KO81312
Aragon Surgical Radiofrequency (RF) System Device Name:
Indications for Use:
The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm.
This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-The-Counter Use Prescription Use or (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Net RP. Oglesby Forman
Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.