SMARTWAND-DTX

K093557 · Clearcount Medical Solutions · LWH · Dec 18, 2009 · General Hospital

Device Facts

• Record ID: K093557
• Device Name: SMARTWAND-DTX
• Applicant: Clearcount Medical Solutions
• Product Code: LWH · General Hospital
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2740
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The ClearCount Medical Solutions SmartWand-DTXTM System is indicated for use in counting and displaying the number of RFID-tagged surgical sponges, laparatomy sponges, and towels detected by the device and providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.

Device Story

System uses handheld scanning antenna and electronics box with RFID reader to detect passive RFID tags embedded in surgical sponges, laparotomy pads, and towels. Device operates by energizing passive tags; tags respond with unique identification data. System displays type and quantity of detected items. Includes 'SmartTag' (business-card sized RFID tag) placed on OR table to provide feedback on scanning proximity. Used in OR by surgical staff to locate retained items. Provides non-invasive detection; aids in surgical sponge counting/reconciliation. Benefits patient by reducing risk of retained surgical items.

Clinical Evidence

Bench testing only. Simulated use in laboratory setting validated software performance and tag location accuracy. Biocompatibility of transponder tags demonstrated. No clinical data presented.

Technological Characteristics

Passive RFID tags; handheld scanning antenna; microcontroller-based reader; proprietary software. Tethered wand design with disposable sterile sheath. Complies with UL 60601-1 and IEC 60601-1-2 (Edition 2.1).

Indications for Use

Indicated for counting and locating RFID-tagged surgical sponges, laparotomy sponges, and towels within a surgical site to prevent retained items.

Regulatory Classification

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.

Predicate Devices

• ClearCount Medical SmartSponge® Plus System (K073180)
• RF Surgical Systems Detection System (K062642)

Submission Summary (Full Text)

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093557

## DEC 1 8 2009

## 5. 510(K) SUMMARY (21 CFR 807.92) CLEARCOUNT MEDICAL SmartWand-DTX® SYSTEM

- 510(k) Owner: ClearCount Medical Solutions, Inc. 101 Bellevue Road, Suite 300 Pittsburgh, PA 15229 Tel: [phone] Fax: [phone]
- Contact Person: Jeff Wolfgong Tel: [phone] ext 109 E-mail: [e-mail]
- Date Prepared: September, 2009
- SmartWand-DTX™ System Trade Name:
- Common Name: Surgical sponge counter
- Classification Name: Surgical sponge counter, unclassified, 21 CFR 888.2740, LWH
- Predicate Devices: ClearCount Medical SmartSponge® Plus System K073180 RF Surgical Systems Detection System K062642
- The SmartWand-DTX™ System is based on radio frequency Device Description: identification (RFID) tags. The RFID tags are provided to manufacturers of surgical disposables for inclusion into their surgical sponges, laparotomy pads and surgical towels. The disposable manufacturer permanently attaches the RFID tags to the gauze or fabric of the disposables. The tags are then programmed to contain information about the type and number of disposables in the package. This allows the sponges, pads, and towels to be individually recognized by an RFID reader. The RFID tag function is the same as that for the SmartSponge Plus System.

The SmartWand-DTX is a device comprised of a handheld scanning antenna that is attached to an electronics box that contains an RFID reader and supporting electronics. Integrated RFID technology allows the capture of the information coded on the unique RFID tags in the sponges, pads and towels. When the tagged sponges, pads, and towels are detected by the scanning wand, the device displays the type and number of each type of item that is detected. The system recognizes RFID-tagged items that may be inside the surgical site.

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A SmartTag is a disposable RFID tag that is approximately the size of a business card. Like the RFID-tagged sponges, the SmartTags contain unique identifying numbers and are distinguishable by the system software. The SmartTag is placed on the operating room table before the patient is brought into the room and is covered by the standard sheets or drapes used in surgery, thus not making contact with the patient. The SmartTag provides feedback to the user that the detection wand is being held close enough to the patient to ensure proper scanning.

Intended Use: The ClearCount Medical Solutions SmartWand-DTX System is indicated for use in counting and displaying the number of RFIDtagged surgical sponges, laparatomy sponges, and towels detected by the device and providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.

> The indications are a subset of those of the ClearCount SmartSponge® Plus predicate device in that it provides a noninvasive means of identifying retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site. This indication is also consistent with the RF Surgical Systems Detection System.

> The ClearCount Medical Solutions SmartWand-DTX System, like the SmartSponge Plus System, relies on permanently affixed radiofrequency identification (RFID) tags to convey unique identification information about each item, unlike the RF Surgical Detection System which uses resonant frequency tags which creates a field disturbance that may indicate the presence of an item.

> The addition of unique identifying information allows the SmartWand-DTX to identify specific attributes, such as the type and quantity of sponges, in an identical manner to the ClearCount SmartSponge Plus predicate device. The ability to distinguish tags uniquely also enables the operation of the SmartTag for aiding in the effective scanning of the surgical site.

Technological Characteristics:

The RFID tags attached to surgical disposables identifies each item to the SmartWand-DTX which reads the tag information with an RFID reader controlled by proprietary software operating on a microcontroller unit. The wand can read the tag through a human body. The device software uses the scanned information to display the type and number of each type of item detected during a scan.

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K093557

The ClearCount SmartWand-DTX System, like the SmartSponge Plus predicate, has a tethered detection wand that uses the same power and control system and same display as the SmartSponge Plus detection wand. The detection wand is used in a similar manner to the RF Surgical Detection System. However, the ClearCount detection wand is provided as a permanent device rather than a single-use disposable. A disposable sterile sheath will be provided for covering the detection wand and the portion of the wand cable that may contact the sterile field.

The SmartWand-DTX System, like the SmartSponge Plus System predicate device, uses RFID technology to communicate unique identification data from tagged items to the reader. This technology is also similar to that of the RF Surgical Detection System predicate, (K062642). Both systems rely on passive tags, which hold no electric charge and remain inactive until energized by a reader in close proximity. RF Surgical tags resonate when excited by a specific radio frequency, causing a specific frequency response which is detected by the RF Surgical Detection Wand. The presence of a resonant tag then alerts the system that a tagged item is within the specified range of the RF Surgical Wand. The ClearCount System also uses a specific radio frequency which causes its passive tags to resonate when within the range of the ClearCount Wand. In the ClearCount System, these tags contain unique identifying information which is stored and used by the device to detect the presence of a tagged item as well as provide descriptive information about the detected items.

The system has also been designed to meet the following electrical safety standards and electromagnetic compatibility standards:

> UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC 60601-1-2 (Edition 2.1 - 2004-11) Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -Requirements and Tests

Non-Clinical

Non-Clinical testing included simulated use of the device in a Performance Data: laboratory setting. The SmartWand-DTX uses the same RFID technology and hardware as the SmartSponge Plus. The performance of the SmartWand-DTX is actually enhanced over the SmartSponge Plus scanning wand in that the wand is pre-tuned

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K093557

thereby making the software algorithm less complex such that the scanning speed is increased. The SmartWand-DTX System performed as intended in the verification and validation testing. 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.

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Conclusions: The data and information demonstrates that the ClearCount SmartWand-DTX™ System provides an added measure of safety and effectiveness to the current methods of gauze and sponge detection presently used in the surgical environments.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

ClearCount Medical Solutions, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313

DEC 1 8 2009

Re: K093557

Trade/Device Name: ClearCount Medical Solutions SmartWand-DTX™ Regulation Number: 21 CFR 880,2740 Regulation Name: Surgical sponge scale Regulatory Class: Class I Product Code: LWH Dated: December 3, 2009 Received: December 4, 2009

Dear Mr. Job:

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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark A. Mcllkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. INDICATIONS FOR USE STATEMENT

K093557 510(k) Number (if known): New Submission

Device Name: ClearCount Medical Solutions SmartWand-DTXTM

Indications For Use: The ClearCount Medical Solutions SmartWand-DTXTM System is indicated for use in counting and displaying the number of RFID-tagged surgical sponges, laparatomy sponge, and towels detected by the device and providing a noninvasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nithip Oglen formen
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number KD93557