(57 days)
The RF Surgical Systems Inc. Detection System is intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods
The RF Surgical Systems Inc. Detection System consists of:
- The Power/Control Console contains the electronics that power and control the detector/scanner. The console also includes the user interface for system operation and communication of the system status, operation and alarms to the user.
- The Transponder/Tag is a single use electrically passive device that is designed to radiate a magnetic signature when stimulated by magnetic impulses from the detector/scanner. The tag does not store or communicate any information or unique code and is to be mechanically attached to guaze sponges at the manufacturing site and processed as part of the item
- The Detection Wand is a transceiver type antenna designed to stimulate the transponder tag assembly with magnetic impulses and then detect the resultant magnetic signature from the tag. The Power/Control Console provides the power and control to the detection scanner. The detection scanner is intended and designed to be a single-use disposable device and will be supplied in a sterile condition as it will enter the surgical field.
Here's an analysis of the acceptance criteria and study information for the RF Surgical Systems Inc. Detection System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, it describes functional requirements and then states that the device "performed as intended."
Based on the "Technological Characteristics" and "Non-Clinical Performance Data" sections, here's an interpretation of the implied acceptance criteria and the reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-invasive means of locating retained surgical sponges, gauze, and other tagged items within a surgical site. | "The RF Surgical Systems Inc. Detection System performed as intended." |
| Detection of tagged objects within a minimum range of 16" from the detector aperture surface into a patient of average size. | Not explicitly quantified, but overall performance "as intended" implies this was met. |
| Tags outside of the patient and more than 36" outside of the scan area must not result in false positives. | Not explicitly quantified, but overall performance "as intended" implies this was met. |
| System capable of reading the tag signal through blood, bodily fluids, and the body wall. | Stated as a characteristic; implicit in "performed as intended." |
| Biocompatibility of the transponder tag comparable to commercially available predicates. | "Biocompatibility of the transponder tag was illustrated and is comparable to the commercially available predicates." |
| Validated software functions as intended, properly locating all tags. | "The validated software functioned as intended under simulated use, properly locating all tags." |
| Meets electrical safety standards: IEC 60601-1. | "The console has also been designed to meet the following electrical safety standards..." (does not explicitly state met in testing, but implies compliance in design). |
| Meets electromagnetic compatibility standards: IEC 60601-1-2 (Second Edition, 2001). | "The console has also been designed to meet the following ... electromagnetic compatibility standards..." (does not explicitly state met in testing, but implies compliance in design). |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not provide a specific numerical sample size for the test set used in non-clinical testing. It mentions "simulated use in patient models" and "Animal studies using large swine species."
- Data Provenance:
- Simulated Use in Patient Models: These are likely laboratory or in-house simulations.
- Animal Studies: "large swine species" were used. The country of origin for these animal studies is not specified, but it's implied to be part of the manufacturer's testing process for FDA submission.
- Retrospective or Prospective: Both "simulated use" and "animal studies" would typically be considered prospective in nature, as they were conducted specifically to test the device.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state that experts were used to establish ground truth in the traditional sense of consensus reading for image analysis. Rather, the ground truth for "locating all tags" in the simulated and animal studies would have been the known physical presence and location of the tagged sponges or items.
4. Adjudication Method for the Test Set
Given the nature of the device (detection of physical tags) and the described testing (simulations, animal studies where tags are physically present), an adjudication method like 2+1 or 3+1 for expert consensus is not applicable. The "ground truth" is directly observable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a standalone performance study of the device itself (detecting tags), not a comparative effectiveness study involving human readers with and without AI assistance (which is not an AI device in the typical sense, but rather a detection system). Therefore, no effect size of human reader improvement is reported.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was conducted. The "Non-Clinical Performance Data" section describes testing where the "RF Surgical Detection System performed as intended" and "the validated software functioned as intended under simulated use, properly locating all tags." This indicates an evaluation of the device's ability to detect tags independently.
7. Type of Ground Truth Used
The ground truth used was:
- Known physical presence and location of tagged items: In simulated patient models and animal studies, the researchers would have known precisely where the tagged sponges were placed.
- Biocompatibility data: For biocompatibility, the ground truth would be established through standard biological testing methods and comparison to known safe materials (predicates), likely through laboratory analysis rather than expert consensus on images.
8. Sample Size for the Training Set
The document does not provide information about a "training set" for the device. This device is described as an RF detection system using transponder tags and a detection wand, not an AI/machine learning system that typically requires a large training dataset. The "software" mentioned likely refers to control and processing logic rather than a trainable AI algorithm.
9. How Ground Truth for the Training Set Was Established
As no training set is indicated, this question is not applicable based on the provided text. The device's operation is based on physical principles of radio frequency detection, not on learning from data.
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510(K) SUMMARY (21 CFR 807.92)
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM
| 510(k) Owner: | RF Surgical Systems Inc.2700 Richards Road, Suite 204Bellevue WA 98005Tel: 425 283 0678Fax: 425 283 0677 |
|---|---|
| Contact Person: | Martin SellersDirector of Manufacturing and RA/QATel: 425 283 0678E-mail: msellers@rfsurg.com |
| Date Prepared: | August 18, 2006 |
| Trade Name: | RF Surgical Systems Inc. Detection System |
| Common: | Surgical Sponge Counter |
| Classification Name: | Surgical Sponge Counter, unclassified, 21 CFR 888.2740 |
| Predicate Devices: | SurgiCount Medical, Safety Sponge™ K060076Tyco/Kendall X-ray Detectable Sponges (Various) 510(k) ExemptTyco Bag-IT Sponge Counting System 510(k) Exempt |
| Device Description: | The RF Surgical Systems Inc. Detection System consists of:1. The Power/Control Console contains the electronics thatpower and control the detector/scanner. The console alsoincludes the user interface for system operation andcommunication of the system status, operation and alarms tothe user.2. The Transponder/Tag is a single use electrically passive device that isdesigned to radiate a magnetic signature when stimulated by magneticimpulses from the detector/scanner. The tag does not store orcommunicate any information or unique code and is to be mechanicallyattached to guaze sponges at the manufacturing site and processed aspart of the item3. The Detection Wand is a transceiver type antenna designed to stimulatethe transponder tag assembly with magnetic impulses and then detect theresultant magnetic signature from the tag. The Power/Control Consoleprovides the power and control to the detection scanner. The detectionscanner is intended and designed to be a single-use disposable deviceand will be supplied in a sterile condition as it will enter the surgical field. |
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Intended Use: The RF Surgical Systems Inc. Detection System is intended to provide a noninvasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods
Technological
The indications are similar those of the predicate devices i.e. "for efficient counting and containment of lap sponges, and for constant visibility for assessing blood loss and counting of sponges."
Characteristics: The RF Surgical Systems Inc. Detection System is analogous to the predicate devices. The Transponder Tag identifies the sponge or gauze to the detection system via a specific radio frequency signal through the single use detection wand. The detection wand can read the tag signal through blood, bodily fluids and the body wall. The 3 element detection system is designed to detect tagged objects(s) within a minimum range of 16" from the detector aperture surface into a patient of average size Tags outside of the patient and more than 36" outside of the scan area must not result in false positives. The console is a durable electro-mechanical assembly that is powered by standard line voltage: 120V. 60Hz and has been designed to work in standard operating rooms or other clinical environments. The console has also been designed to meet the following electrical safety standards and electromagnetic compatibility standards:
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2 (Second Edition, 2001) Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests
The wand is a transceiver type antenna designed to stimulate the transponder tag assembly with magnetic impulses and then detect the resultant magnetic signature from the tag. The Power/Control Console provides the power and control to the detection scanner.The detection scanner is intended and designed to be a single-use disposable device and will be supplied in a sterile condition as it will enter the surgical field. The Scanner consists of two-part plastic handle that encloses a wire loop antenna, a capacitor and a fuse. The antenna consists of and arrangement of multiple turns of a copper magnet wire with a specific diameter. The copper magnet wire is insulated with an enamel coating. An electrical fuse and series capacitor is wired between the ends of the antenna winding. The antenna is attached to a standard RG-58 50Ω coaxial cable with a standard 50Ω BNC Connector.
The tag is an electrically passive device that is designed to radiate a magnetic signature when stimulated by magnetic impulses from the detector/scanner. The tag does not store or communicate any information or unique code, rather it responds at its resonant frequency, which by design falls within a specific band of operation and which the detection system is designed to identify . All tags resonate at the same frequency within the band of operation, and only the presence of a tag is indicated even should more than one be present.
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Non-Clinical
Performance Data: Non-Clinical testing included simulated use in patient models that represented worst case biological situations as well as manufacturing process situations and in all cases the RF Surgical Detection System performed as intended. Animal studies using large swine species further substantiate the satisfactory performance of the detection system. Biocompatibility of the transponder tag was illustrated and is comparable to the commercially available predicates. The validated software functioned as intended under simulated use, properly locating all tags. This testing supports a determination of substantial equivalence to products and technologies previously cleared by FDA.
Conclusions: The data and information demonstrates that the RF Surgical Systems Inc. Detection System provides an added measure of safety and effectiveness to the current methods of gauze and sponge counting presently used in the surgical and clinical environments,
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle in flight, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RF Surgical Systems, Inc. % Mr. Kevin Cosens President & CEO 2700 Richards Road, Suite 204 Bellevue, Washington 98005
NOV - 2 2006
Re: K062642
Trade/Device Name: RF Surgical Systems Inc. Detection System Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH Dated: September 1, 2006 Received: September 6, 2006
Dear Mr. Cosens:
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 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.
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Page 2 - Mr. Kevin Cosens
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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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Intended Use Statement
510(k) Number (if known): K062642
Device Name: RF Surgical Systems Inc. Detection System
Indications for Use:
The RF Surgical Systems Inc. Detection System is intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.O. Ramos
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number L062642
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§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.