SURGICOUNT SAFETY-SPONGE SYSTEM

K060076 · Surgicount Medical · LWH · Mar 14, 2006 · General Hospital

Device Facts

• Record ID: K060076
• Device Name: SURGICOUNT SAFETY-SPONGE SYSTEM
• Applicant: Surgicount Medical
• Product Code: LWH · General Hospital
• Decision Date: Mar 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2740
• Device Class: Class 1

Indications for Use

The SurgiCount Medical Safety-Sponge System™ is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.

Device Story

System comprises thermally labeled surgical sponges/towels and a mobile computer with specialized software. Each sponge/towel features a unique identification label. During surgery, a handheld laser imager scans labels to track items entering and exiting the surgical field. Software records initial counts, tracks items in use, and reports totals on demand or at procedure end. Used in surgical settings by operating personnel. Provides real-time inventory management to ensure all sponges are accounted for before surgical closure. Benefits patient by reducing risk of retained surgical items.

Clinical Evidence

Clinical study conducted under non-significant risk IRB approval in a surgical setting. Evaluated accuracy of sponge counts (in/out of field, clean/soiled), time efficiency, and ease of use. Results demonstrated the system functioned as intended, accurately counting sponges with no adverse events reported. Data supported substantial equivalence to existing manual counting and inventory control methods.

Technological Characteristics

Non-absorbable gauze sponges/towels with x-ray detectable strips and unique thermally attached identification labels. System uses a mobile computer with a handheld laser imaging scanner. Software performs inventory counting and reporting. Connectivity via mobile hardware platform. Biocompatible materials.

Indications for Use

Indicated for use in counting and recording thermally labeled surgical sponges, laparotomy sponges, and towels during surgical procedures.

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

• Tyco/Kendall X-ray detectable surgical sponges
• Tyco BAG-IT Sponge Counting System
• SMS Blood Bank Transfusion System (BK960036)

Submission Summary (Full Text)

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K060076

Image /page/0/Picture/1 description: The image shows the logo for Surgicount Medical. The logo consists of a grid of black squares on the left, followed by the word "SURGICOUNT" in large, bold letters. Below that, the word "MEDICAL" is written in white letters on a black background. The text "A Division of Patient Safety Technologies, Inc." is below the black background, and the phrase "You Can Count On Us TM" is at the bottom.

MAR 1 4 2006

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27555 Ynez Road, Suite 3 emecula, CA 92591 P: 951-587-6201, F: 951-587-6

## 510(K) SUMMARY (21 CFR 807.92)

#### SURGICOUNT MEDICAL SAFETY-SPONGE SYSTEM

- SurgiCount Medical division of Patient Safety Technologies, Inc. 510(k) Owner: 27555 Ynez Road, Suite 330 Temecula, CA 92591 Tel: [phone] Fax: [phone]
- Contact Person: Sharon Rockwell Tel: [phone] E-mail: [e-mail]
- Date Prepared: December, 2005
- Trade Name: Safety Sponge™ System
- Common Name: Surgical sponge and surgical sponge counter
- Classification Name: Nonabsorbable gauze for internal use per 21 CFR 878.4450, GDY Surgical sponge counter, unclassified, 21 CFR 888.2740, LWH
- Predicate Devices: Tyco/Kendall X-ray detectable surgical sponges Tyco BAG-IT Sponge Counting System SMS Blood Bank Transfusion System, BK960036
- Device Description: The Safety Sponges include surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique identification label permanently fused to the gauze or fabric. The labels allow the sponges and towels to be individually recognized by a commercially available sight laser imager.

The Safety Sponge Counter is a commercially available mobile computer with specialized software designed for mobile data collection. Integrated imaging technology allows capture of the information coded in the unique identification label on the sponges, pads and towels. The computer counts the initial number of sponges opened, and using the custom software program, reports the total sponges used at the end of the procedure or on

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demand, and compares that number to the original. Individual sponges may be identified as entered into the surgical field but not discarded, so that the surgical field can be explored before surgically closing the patient.

The SurgiCount Medical Safety-Sponge System is indicated for Intended Use: use in counting and recording the number of thermally labeled surgical sponges, laparatomy sponges and surgical towels used during surgical procedures.

> The indications are similar to those of the predicate device, BAG-IT Sponge Counting System by Tyco; "for efficient counting and containment of lap sponges, and for constant visibility for assessing blood loss and counting of sponges."

> The SurgiCount Medical indications are also comparable to a software module from Advanced Medical Systems (AMS), approved under 510(k) BK960036, "for inventory management of bank transfusion systems, which require unique blood identifications." Though the AMS software module is used for blood bags, it is designed to run on general purpose hardware platforms supplied by commercial manufacturers, and records patient identification, counts of blood bags in different stages of inventory, and reports the total number of bags in a particular location, or on demand. The counting of blood bags is comparable to the counting of surgical sponges and is not critical to the intended use of the software.

Technological Characteristics:

Surgical sponges from SurgiCount Medical arc identical to those of Tyco/Kendall in terms of technological characteristics. Both are non-absorbable gauze with x-ray detectable strips. The SurgiCount Medical sponges, pads and towels have a unique identifying label thermally attached to every sponge, pad and towel. The thermal label identifies the product to the hand held scanner which reads the label with a commercially available laser imaging reader on a mobile computer. The scanner can read the label through blood and bodily fluids. A customized software program, similar to the predicate software for inventory control of blood bags, uses the scanned information to count the number of items used at the beginning of a surgical procedure, and then again at appropriate times as indicated by hospital practice, such as just before surgical closure. The sponge count in and out of the procedure can be helpful in determining if any sponges may of the Procedural sponge counts can be obtained on inside a patient.

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demand from the mobile computer, or at the end of the procedure for a permanent report.

Non-Clinical

Non-clinical testing included demonstrating permanence of the Performance Data: label on gauze pads, biocompatibility of the label material, manufacturing validation that one and only one unique label was placed per pad, software validation of the hand-held scanning device, and simulated finished product testing of the total system. Results showed that the gauze labels do not flake or peel, 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 and providing hard copy reports equivalent to those used for blood bag inventory products. The testing supports a determination of substantial equivalence to products and technologies previously cleared by FDA.

- The SurgiCount Safety-Sponge System has been tested clinically Clinical Data: under non-significant risk IRB approvals in a surgical setting. The device functioned as intended, and accurately counted surgical sponges into and out of the field, on both clean and soiled sponges. The study compared accuracy of sponge counts as well as time spent for counting sponges, and operating personnel's assessment of the software program and ease of use. No adverse events were Results supported substantial equivalence to reported. commercially available surgical sponges and counters used for inventory control of other medical devices.
- The non-clinical and clinical test results demonstrate the thermally Conclusions: labeled sponges are as safe as the predicate device, and the software installed on the commercially available mobile computer performs accurately, making its use more effective than hand counting sponges. The system provides improved accuracy, comparable to inventory control systems used for blood bag counting.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing health, services, and human. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2006

SurgiCount Medical c/o Rockwell & Associates Ms. Sharon Rockwell 5582 Chalon Road Yorba Linda, California 92886

Re: K060076

Trade/Device Name: SurgiCount Medical Safety-Sponge System Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH Dated: December 21, 2005 Received: January 10, 2006

Dear Ms. Rockwell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosare) to tegals) to tegals (1976) the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical For J. Day commerce proof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of use ice, 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 (500 a00 roy ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contributi may be subject to such additional controller Listing of 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 Flease be advised that 11971 is issuance or our device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of any I cacal statutes and regenanents, including, but not limited to: registration and listing (21 Comply with an the Hel 37equirements) (1); good manufacturing practice requirements as set Of It Fart 607); adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality by over of sions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Sharon Rockwell

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls ough finding of substantial equivalence of your device to a legally prematics notification. The stars 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 ir you deems of Compliance at [phone]. 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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
dl.mde

Mark N. Melke Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SurgiCount Medical Traditional 510(k) Safety-Sponge System™

K060076

December, 2005

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K060076

Device Name: SurgiCount Medical Safety-Sponge System™

Indications for Use:

The SurgiCount Medical Safety-Sponge System™ is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.

Prescription Use (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)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_ Ko60076