(9 days)
The ClearCount Medical Solutions SmartSponge™ System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures.
The SmartSponge™ System includes surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique radio frequency identification (RFID) tag permanently attached to the gauze or fabric. The tags allow the sponges and towels to be individually recognized by an RFID reader.
The SmartBucket is a specially designed cart containing a microcontroller unit with specialized software designed for mobile data collection. Integrated RFID technology allows capture of the information coded on the unique RFID tag on the sponges, pads and towels. The microcontroller unit counts the initial number of sponges introduced into a surgical case, and using the custom software program, reports the total sponges discarded at the end of the procedure, and compares that number to the original. By providing a count of the items entered into surgery, and a count of those discarded and removed permanently from the surgical field, personnel can be alerted to sponges that may still remain in the surgical field prior to closing the patient.
The ClearCount Medical Solutions SmartSponge™ System is designed to count and record RFID-tagged surgical sponges, laparotomy sponges, and surgical towels during surgical procedures. The provided text outlines non-clinical performance data and results.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Permanence of the RFID tag on gauze pads | "Results showed that the tags are permanently attached." |
| Biocompatibility of the RFID tag material | "material is comparable to commercially available predicates in terms of biocompatibility." |
| Manufacturing validation: each item has one and only one unique tag | "manufacturing validation that one and only one unique tag was placed per item." |
| Software validation of the SmartBucket scanning device: proper counting in simulated body fluids | "The validated software functioned as intended under simulated use, properly counting sponges in simulated body fluids." |
| Overall system performance: safety and accuracy compared to manual counting | "Test results demonstrate the RFID tagged sponges are as safe as the predicate device, and the software installed on the microcontroller unit performs accurately, making its use more effective and more accurate than hand counting sponges." |
2. Sample size used for the test set and the data provenance:
The document states "simulated finished product testing of the total system" and "properly counting sponges in simulated body fluids." However, it does not specify the sample size for this test set nor the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth for counting accuracy was established through "simulated use, properly counting sponges in simulated body fluids," implying a controlled experimental setup rather than expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
The document does not specify an adjudication method (such as 2+1 or 3+1) for the test set. Given the nature of the device (counting sponges), the ground truth for counting accuracy would likely be directly observable and verifiable rather than requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document compares the device's accuracy and effectiveness to "hand counting sponges" but does not provide specific effect sizes for human readers with or without AI assistance in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done implicitly. The "software validation of the SmartBucket scanning device" and "simulated finished product testing of the total system" describe the device's ability to "properly count sponges" without human intervention for the counting process itself. The system is designed to provide a count that personnel then use to determine if sponges remain.
7. The type of ground truth used:
The ground truth used for the counting accuracy of the SmartSponge System was directly observable and verifiable counts in simulated use conditions, specifically "properly counting sponges in simulated body fluids." This is an objective measurement of the device's functionality rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
The document does not specify the sample size for any training set. Given the context of a 2007 510(k) submission for a device using RFID for counting, it's possible that traditional "training sets" in the modern machine learning sense were not explicitly defined or reported in the same way. The software validation suggests a designed and tested algorithm rather than a continuously learning AI model.
9. How the ground truth for the training set was established:
The document does not describe how ground truth for a training set (if one was formally used) was established. The software validation likely involved testing against known, correct counts of sponges in controlled environments.
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Image /page/0/Picture/0 description: The image shows the logo for ClearCount Medical Solutions. The logo consists of a stylized plus sign to the left of the word "clearcount". Below the word "clearcount" are the words "MEDICAL SOLUTIONS" in a smaller font. There is a long line of dashes to the right of the words "MEDICAL SOLUTIONS".
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MAY 2 4 2007
5. 510(K) SUMMARY (21 CFR 807.92) CLEARCOUNT MEDICAL SMARTSPONGE™ SYSTEM
| 510(k) Owner: | ClearCount Medical Solutions, Inc.700 River Avenue, Suite 100Pittsburgh, PA 15212Tel: 412-322-4110Fax: 412-291-1091 |
|---|---|
| Contact Person: | Steven FleckTel: 412-322-4110E-mail: steve@clearcount.com |
| Date Prepared: | October, 2006 |
| Trade Name: | SmartSponge™ System |
| Common Name: | Surgical sponge and surgical sponge counter |
| Classification Name: | Nonabsorbable gauze for internal use per 21 CFR 878.4450, GDYSurgical sponge counter, unclassified, 21 CFR 880.2740, LWH |
| Predicate Devices: | Dukal Corporation X-ray detectable surgical spongesSurgiCount Medical, Inc. Safety-Sponge System, K060076Digital Angel Corporation VeriChip implantable radio frequencytransponder system, K033440 |
| Device Description: | The SmartSponge™ System includes surgical sponges, laparatomypads and surgical towels, each unit of which contains a uniqueradio frequency identification (RFID) tag permanently attached tothe gauze or fabric. The tags allow the sponges and towels to beindividually recognized by an RFID reader.The SmartBucket is a specially designed cart containing amicrocontroller unit with specialized software designed for mobiledata collection. Integrated RFID technology allows capture of theinformation coded on the unique RFID tag on the sponges, padsand towels. The microcontroller unit counts the initial number ofsponges introduced into a surgical case, and using the customsoftware program, reports the total sponges discarded at the end ofthe procedure, and compares that number to the original. Byproviding a count of the items entered into surgery, and a count ofthose discarded and removed permanently from the surgical field,personnel can be alerted to sponges that may still remain in thesurgical field prior to closing the patient. |
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Intended Use:
The ClearCount Medical Solutions SmartSponge™ System is indicated for use in counting and recording the number of RFIDtagged surgical sponges, laparatomy sponges and towels used during surgical procedures.
The indications are similar to those of the predicate device, the SurgiCount Medical Safety-Sponge System; "for use in counting and recording the number thermally labelled surgical sponges, laparatomy sponges and towels used during surgical procedures." The ClearCount Medical SmartSponge™ System relies on permanently affixed radiofrequency identification tags rather than thermal labels to convey unique identification information about each item. The counting of items in each system is otherwise comparable, and the mode of communication is not critical to the intended use of the device and its software.
Technological Characteristics:
Surgical sponges from ClearCount Medical Solutions are identical to those of Dukal Corporation in terms of technological characteristics. Both are non-absorbable gauze with x-ray detectable strips. The ClearCount Medical Solutions sponges, pads and towels have a unique radiofrequency identification tag securely sewn into every sponge, pad and towel. The tag identifies the product to the SmartBucket cart which reads the label with a commercially available RFID reader controlled by specialized software operating on a microcontroller unit. The scanner can read the tag through blood and bodily fluids. A customized software program, similar to the predicate software for the SurgiCount Medical Safety-Sponge System, uses the scanned information to count the number of items used at the beginning of a surgical procedure, and then again before surgical closure. The sponge count in and out of the procedure can be helpful in determining if any sponges may still be inside a patient. Procedural sponge counts can be obtained on demand from the mobile computer, or at the end of the procedure for a final report.
SmartSponge™ System The uses RFID technology communicate unique identification data from tagged items to the reader. This technology is similar to that used in the Digital Angel Corporation's VeriChip implantable radio frequency transponder system, (K033440). Both systems rely on passive RFID tags, which hold no electric charge and remain inactive until energized by an RFID reader in close proximity. Digital Angel's VeriChip transponders store and communicate a unique identification number which may be used to access a database containing the
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K071355 page 3/3
patient's identity and health information. ClearCount's transponders store and communicate a unique identification number which is used to catalog each item used in a particular surgery.
Non-Clinical Performance Data:
Non-clinical testing included demonstrating permanence of the tag on gauze pads, biocompatibility of the tag material, manufacturing validation that one and only one unique tag was placed per item. software validation of the SmartBucket scanning device, and simulated finished product testing of the total system. Results showed that the tags are permanently attached, and that the material is comparable to commercially available predicates in terms of biocompatibility. The validated software functioned as intended under simulated use, properly counting sponges in simulated body fluids. The testing supports a determination of substantial equivalence to products and technologies previously cleared by FDA.
Conclusions:
Test results demonstrate the RFID tagged sponges are as safe as the predicate device, and the software installed on the microcontroller unit performs accurately, making its use more effective and more accurate than hand counting sponges.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The text is written in all capital letters.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ClearCount Medical Solutions, Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio
MAY 2 4 2007
Re: K071355
Trade/Device Name: ClearCount Medical Solutions SmartSponge" System Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH, GDY Dated: May 14, 2007 Received: May 15, 2007
Dear Mr. Lehtonen:
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 (OS) 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. Daniel W. Lehtonen
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,
Barbara Owens
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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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): New Submission
Device Name: ClearCount Medical Solutions SmartSponge™ System
Indications For Use: The ClearCount Medical Sofutions SmartSponge™ System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparotomy sponges, and surgical towels used during surgical procedures.
Prescription Use X (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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deubare Buellun
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K071355
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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.