The ORLocate™ system is indicated for use in recording and counting the number of RFID-tagged surgical sponges, laparotomy sponges, towels and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained RFID-tagged surgical sponges, towels and other tagged items within a surgical site, as an adjunctive detection method to current surgical counting systems and methods.

Device Description

Haldor ORLocate™ system is an RFID system providing a solution that enables the enumeration of sponges and surgical manual instruments, utilizing passive tags for keeping track of the items during surgery and to identify counting problems. In addition, the system provides a non-invasive means of locating retained surgical items within a surgical site. The submission consists of the ORLocate™ system which includes: cart and antennas. Additionaly the submission includes accessories which are: associated single use surgical sponges, gauzes, pads and surgical towels each fitted with a uniquely coded RFID tag and uniquely coded RFID tag used for surgical instruments. The RF frequency the system uses is 13.56 MHz according to ISO 15693. The system supplies also a semi-automatic application to help in counting untagged items, the count information is first entered manually and the calculations are automatic.

AI/ML Overview

The ORLocate™ System is an RFID-based system for counting and detecting surgical items. The provided document, a 510(k) Summary, details the device's technical characteristics, intended use, and non-clinical performance data to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. However, based on the non-clinical performance data section, the criteria can be inferred from the tests performed and the conclusion that the device functions as intended and is as safe and effective as predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility of tagged items	Demonstrated
Permanent attachment of tags to sponges and instruments	Demonstrated
Software functions as intended	Validated, properly counting sponges in body fluids
Safety equivalent to predicate devices	Test results demonstrate this
Effectiveness equivalent to predicate devices	Test results demonstrate this
Proper functioning in body fluids	Software properly counted sponges in body fluids
Counting accuracy	Testing performed, deemed "as safe and effective"
System interference with OR devices	Testing performed
ORLocate sponge X-ray detection	Testing performed
ORLocate Tag pull test	Testing performed
Electromagnetic compatibility (IEC 60601-1-2:2007)	Testing performed
Electrical safety (IEC 60601-1:1988 + A1:1991 + A2:1995 and EN 60601-1:1990 + A1:1993 + A2:1995 + A3:1996)	Testing performed

2. Sample Size Used for the Test Set and Data Provenance

The document states "Non-clinical testing included demonstrating performance of system and tagged items in laboratory tests." However, it does not specify the sample sizes used for any of the tests (e.g., how many sponges were tested for counting accuracy, how many instruments for tag pull test).

The data provenance is described as "laboratory tests," implying controlled settings rather than real-world clinical data. The document does not mention the country of origin of the data explicitly, but the 510(k) owner is based in Israel, suggesting the testing likely occurred there or in collaboration with international labs. The study is retrospective in the sense that the testing was performed and then reported for the 510(k submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of the non-clinical tests (e.g., biocompatibility, tag attachment, software counting accuracy), ground truth would likely be established through objective measurements and validated procedures rather than solely expert consensus.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given that the non-clinical tests are largely objective performance evaluations (e.g., measuring count accuracy, pull force, EMC compliance), an adjudication method in the context of expert review is unlikely to be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on non-clinical performance data to establish substantial equivalence, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the non-clinical tests described are essentially standalone performance evaluations of the algorithm and device. The "counting accuracy test" and validation that the "software functioned as intended under simulated use, properly counting sponges in body fluids" demonstrate the algorithm's performance without direct human-in-the-loop assistance for the core counting mechanism. The system is designed to perform automatic counts and provide alerts if items are missing, which is a standalone algorithmic function.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would have been established through:

Objective measurement/validation: For counting accuracy, the actual number of sponges present would be the ground truth. For tag pull tests, the measured force would be compared against a standard.
Established standards: Compliance tests like IEC 60601-1-2:2007 and IEC 60601-1:1988 + A1:1991 + A2:1995 refer to external ground truths established by international standards bodies.
Simulated environment: For the software, simulated body fluids were used to test performance, implying a controlled and known environment against which the device's output was compared.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The system described is an RFID detection and counting system, which typically relies on pre-programmed logic for tag identification and counting, rather than a machine learning model that requires a "training set" in the conventional sense. If there are any adaptive or learning components, they are not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not mentioned for machine learning purposes, the method for establishing its ground truth is not applicable/not provided. The system's operational parameters (e.g., RFID tag protocols, counting logic) would be established through engineering design and validation, not model training.

Summary

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K10055 I

AUG 122 2010

IV. 510(K) SUMMARY

510(k) SUMMARY (21 CFR 807.92) ORLocate™ System

510(k) Owner:

Haldor Advanced Technologies Ltd. 2 Habanai st., Hod Hasharon, 45319 Israel Tel: +972 9 788 5867 Fax: +972 9 788 5861

Sarit Gal-Rom Gelbart Contact Person: Regulatory Consultant H.M.Da Consulting & Development Ltd. Tel +972 523 599 870 Email: sarit.gelbart@gmail.com

Or

Morr Avissara Product Manager Haldor Advanced Technologies Ltd. Tel: +972 52 868 5650 Email: morr.avissara@haldor-tech.com

Feb. 20th 2010 Date Prepared:

Name:

ORLocate™ System Trade Name:

Surgical Items Counting System Common:

Surgical sponge counter, Class I, 21 CFR 880.2740, LWH Classification

Nonabsorbable gauze for internal use, Class I, 21 CFR 878.4450, GDY

Predicate Clearcount Medical SmartSponge K071355 RF Surgical Systems Inc. detection system, K062642 Devices: SurgiCount Medical, Inc. Safety-Sponge System, K060076

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KIDOSS I 2/4

Device Description: Haldor ORLocate™ system is an RFID system providing a solution that enables the enumeration of sponges and surgical manual instruments, utilizing passive tags for keeping track of the items during surgery and to identify counting problems. In addition, the system provides a non-invasive means of locating retained surgical items within a surgical site.

The submission consists of the ORLocate™ system which includes: cart and antennas. Additionaly the submission includes accessories which are: associated single use surgical sponges, gauzes, pads and surgical towels each fitted with a uniquely coded RFID tag and uniquely coded RFID tag used for surgical instruments. The RF frequency the system uses is 13.56 MHz according to ISO 15693.

The system supplies also a semi-automatic application to help in counting untagged items, the count information is first entered manually and the calculations are automatic.

From this point on the system cart and antennas will be referred to as the "ORLocate™ system," sponges fitted with Haldor RFID tag will be referred to as "RFID tagged sponge" or "RFID tagged item" and a manual surgical instrument fitted with Haldor RFID tag will be referred to as "RFID tagged surgical instrument" or "RFID tagged item" too.

The system detects each RFID tagged item placed on top of the system antennas prior to surgery and creates an inventory of all sponges (e.g. gauzes, pads) and instruments. The user can also register new items during surgery and the inventory is updated automatically after the new items are scanned in an RFID antenna. The system performs automatic count of all inventory every 5 minutes and also performs count upon user request.

At the end of the procedure, final counts are provided by the system and in the case that any items are missing the mobile antenna may be used to search the surgical site for the retained RFID tagged item.

Intended Use:

The indications are similar to those of the predicate device ClearCount SmartSponge system: "for use in counting and recording the number of RFID tagged surgical sponges, laparatomy sponges and towels used during surgical procedures." The

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indications are also similar to those of the predicate device RF Surgical Systems Inc. Detection System: "intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site."

Technological Characteristics:

The ORLocate™ System is analogous to the predicate devices. Similar to the ClearCount SmartSponge System and the RF Surgical Systems Inc. Detection System, the system is comprised of a cart that contains the computer, processing units and connected antennas which can detect tags via a specific radio frequency signal. The tags are attached to surgical sponges and surgical instruments to enable the enumeration of the items. The RFID tag is securely sewn to each sponge, gauze or towel in the same manner as in the ClearCount SmartSponge System. A second type of RFID tag is securely attached to surgical instruments The mobile antenna in RF Surgical and the ORLocate™ system can read the tag signal through blood, bodily fluids and the body wall.

The customized software program, similar to the predicate software for the ClearCount SmartSponge System, uses the scanned and recorded information to count the number of items at the beginning of a surgical procedure, during and then again before surgical closure. A count can be obtained on demand from the computer and locates each item in antenna range. The count at the end of the surgery can be helpful in determining if any sponges are missing and may still be inside a patient.

Non-Clinical Performance Data:

Non-clinical testing included demonstrating performance of system and tagged items in laboratory tests. Tests demonstrated biocompatibility of tagged items, and permanent attachment of the tags to both sponges and instruments. The validated software functioned as intended under simulated use, properly counting sponges in body fluids. Test results also demonstrate the RFID tagged sponges and instruments are as safe as the predicate devices and the software installed on the system cart computer provides an added measure of safety and effectiveness to current methods of sponge and instrument counting presently used in the surgical and clinical environments. Pertinent testing done on this device include: system interference with operating room devices, ORLocate sponge X-ray detection, ORLocate Tag pull test, counting accuracy test, electromagnetic compatibility testing per IEC 60601-1-2:2007 and electrical safety testing per IEC 60601-1:1988 + A1:1991 + A2:1995 and EN 60601-1:1990 + A1:1993 + A2:1995 + A3:1996. The testing supports a determination of substantial equivalence to products and technologies previously cleared by FDA.

Conclusions:

the ORLocate system and accessories are In conclusion, substantially equivalent to the predicate devices identified. In addition, non-clinical performance data and test results demonstrate

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the product is as safe and effective for its intended use as its predicate devices.

: ・

: 100 - 100 - 100 -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the bird. The text is oriented in a circular fashion, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES USA" on the right side.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Haldor Advanced Technologies, Ltd. % H.M.Da Consulting and Development Sarit Gelbart Gal-Rom 107 Shavey Tzion Pardes Hanna 37052 Israel

Re: K100551

Trade/Device Name: ORLocate™ system Regulation Number: 21 CFR 880.2740 -Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH Dated: June 17, 2010 Received: June 23, 2010

Dear Sarit Gelbart Gal-Rom:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class I! (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

AUG 12 2010

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Page 2 - Sarit Gelbart Gal-Rom

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 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Mellhess

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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INDICATIONS FOR USE STATEMENT III.

Indications for Use

AUG 122 2010

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

Device Name: ORLocate™ system

Indication for use: The ORLocate™ system is indicated for use in recording and counting the number of RFID-tagged surgical sponges, laparotomy sponges, towels and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained RFID-tagged surgical sponges, towels and other tagged items within a surgical site, as an adjunctive detection method to current surgical counting systems and methods.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Daniel Knaefoeluxm
(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K100551

Regulation Number and Section

§ 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.