The Pre-Loaded Visicoil a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm. The Pre-Loaded Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method. Depending on the coil size (0.35mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle.

AI/ML Overview

This 510(k) submission (K070305) for the RadioMed™ Soft Tissue Marker (Pre-Loaded Visicoil Marker) is a Special 510(k), which implies that the fundamental scientific technology and the intended use of the modified device have not changed from the predicate device (Visicoil™ Marker, K031206). Therefore, the performance testing focuses on demonstrating that the device continues to meet established safety and effectiveness criteria, particularly considering the changes introduced (pre-loading in the needle and sterilization method change).

The provided document does not contain a detailed study report with specific quantitative acceptance criteria or a comprehensive clinical study. Instead, the submission relies on the established substantial equivalence to the predicate device and adherence to regulatory standards.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or a "reported device performance" section with metrics like sensitivity, specificity, accuracy, etc., as typically seen in submissions for AI/diagnostic devices.
Instead, it indicates that the device has passed adherence to regulatory and manufacturing standards.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Functional Equivalence	The modified device (Pre-Loaded Visicoil) maintains the same fundamental scientific technology and intended use as the predicate device (Visicoil™ Marker). This implies that its radiographic marking capabilities remain unchanged.	The "Comparison of Technological Characteristics" states: "The fundamental scientific technology of the modified device has not changed." and "The design of the predicate Visicoil Marker is identical to the Pre-Loaded Marker." The "Intended Use" and "Indications for Use" are also stated as unchanged. This indirectly confirms that the performance in marking soft tissue for future therapeutic procedures is maintained.
Sterilization Efficacy	The new sterilization method (Ethylene Oxide - EO) must effectively sterilize the device to ensure patient safety. This implies meeting industry standards for sterility assurance.	"Sterilization is achieved by a validated EO sterilization method." While specific validation data (e.g., Sterility Assurance Level - SAL) is not provided in this summary, the statement indicates that a validated method is used, implying successful performance against sterility criteria.
Biocompatibility	The materials used for the device must be biocompatible with human tissue, especially since the change involves pre-loading in a delivery needle. The gold coil material is assumed to be biocompatible, as it's identical to the predicate. The new needle and any associated components must also be biocompatible. (Not explicitly mentioned as a new test but implicitly covered by relying on predicate and QSR).	Not explicitly detailed in the provided text. However, adherence to FDA QSR Part 820 ("Good Manufacturing Practices") implicitly covers material and process controls that ensure biocompatibility. Since the core gold coil material is identical to the predicate, and the needle type (CP Medical, Class I exempt) is standard, new biocompatibility testing might not have been deemed necessary beyond standard QSR compliance.
Device Integrity/Stability	The pre-loading of the coil within the needle must not compromise the integrity of the coil (e.g., kinking, damage) or its ability to be deployed effectively. The device must also remain stable throughout its shelf life under the new sterilization and packaging. (Not explicitly mentioned as a new test but implicitly covered by relying on predicate and QSR).	"Pre-Loaded Visicoil is packaged sterile, for single use." "To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures." This implies that the device integrity and functionality for deployment are verified at manufacturing.
Manufacturing Quality	Compliance with the FDA Quality System Regulation (QSR) 21 CFR Part 820.	"The Pre-Loaded Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR." "Summary of standards achieved: FDA QSR 21 CFR Part 820 Good Manufacturing Practices." This indicates adherence to established quality and control procedures for manufacturing.

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

Test Set Sample Size: The document does not specify a sample size for a separate "test set" in the context of clinical performance or human reader studies. This submission is for a modified device and relies on showing substantial equivalence, rather than new clinical efficacy data.
Data Provenance: Not applicable in the context of a new clinical study. The data provenance implicitly stems from the predicate device's established performance and the manufacturer's internal validation of manufacturing and sterilization processes.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The document does not describe a study involving expert readers or the establishment of ground truth by experts for a new diagnostic or interpretative purpose.
Qualifications of Experts: Not applicable.

4. Adjudication Method

Adjudication Method: Not applicable. There is no mention of a study involving human interpretation or a need for adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described in this document. This is not a study about human readers improving with or without AI assistance but rather a device modification submission.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, a standalone performance study (algorithm only) was not conducted or described. This device is a physical marker, not a diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the purposes of this submission, the "ground truth" is implicitly the established safety and effectiveness of the predicate device and the validated performance of the manufacturing and sterilization processes. There is no new "ground truth" established as part of a diagnostic accuracy study.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document is not describing an AI/machine learning device that would require a training set.

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

Training Set Ground Truth: Not applicable for the reasons stated above.

Summary

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Ko70305

Special 510k Submission

RadioMed Corporation January 25, 2007

Section J

510k Summary

Sponsor Name

MAR 0 7 2007

Visicoil Marker

sor Name	RadioMed Corporation
	One Industrial Way
	Tyngsboro, Massachusetts 01879-1400
Telephone:	(978) 649-0300 voice
	(978) 649-0333 fax
Contact Individual:	Gordon Roberts

2. Device Name

Proprietary Name:	RadioMed™ Soft Tissue Marker
Common/Usual Name:	RadioMed™ Soft Tissue Marker
Classification Name:	System X-Ray, Tomography, Computed

3. Identification of Predicate or Legally Marketed Device The predicate devices for RadioMed™ Soft Tissue Marker are:

1. Visicoil™ Marker (K031206)
1. 17, 18, 19g Needles manufactured by CP Medical (Class I exempt)

4. Device Description

The Pre-Loaded Visicoil a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm.

The Pre-Loaded Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method.

The Pre-Loaded Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.

Depending on the coil size (0.35mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle.

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RadioMed Corporation January 25, 2007

Visicoil Marker Special 510k Submission

5. Intended Use

The intended use and indications for use of the modified device, as described in its labeling has not changed.

The Pre-Loaded Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

1. Comparison of Technological Characteristics
  The fundamental scientific technology of the modified device has not changed.

Predicate Device: Visicoil Marker

510(k) Number: K 031206

The design of the predicate Visicoil Marker is identical to the Pre-Loaded Marker. It is a gold metallic coil, ranging from one centimeter to six centimeters in length for the 0.35mm and 0.75mm versions and one centimeter to three centimeter for the 1.2mm version. Note: The 1.2mm version is nominally sized at 1.1mm and is referenced as this size on the product label.

The changes to this product include:

Pre-Loaded in the delivery needle
8 Sterilization method - Ethylene Oxide as opposed to Gamma Irradiation
1. Performance Testing

Summary of standards achieved:

FDA QSR 21 CFR Part 820 Good Manufacturing Practices

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Image /page/2/Picture/0 description: The image shows a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal, there is a stylized emblem consisting of three curved lines that resemble a human figure or a symbol representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Gordon Roberts Director, Quality Assurance and Regulatory Affairs RadioMed Corporation One Industrial Way TYNGSBORO MA 01879

MAR 07 2007

Re: K070305

Trade/Device Name: Pre-Loaded Visicoi]TM Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.1750 Regulatory Name: Computed tomography x-ray system Regulatory Class: II Product Code: IYE and JAK Dated: January 25, 2007 Received: February 5, 2007

Dear Mr. Roberts:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. Three stars are arranged beneath the word "Centennial". The logo is black and white and has a slightly distressed or vintage appearance.

Protecting and Promoting Public Health

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Page 2 -

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.

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

070305

Pre-Loaded VisiCoil

Pre-Loaded VisiCoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legmann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 11/10 30 510(k) Number __

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.