SPEC Model M16

K150895 · Source Production and Equipment Co., Inc. · KXK · Jun 19, 2015 · Radiology

Device Facts

• Record ID: K150895
• Device Name: SPEC Model M16
• Applicant: Source Production and Equipment Co., Inc.
• Product Code: KXK · Radiology
• Decision Date: Jun 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of SPEC Model M16 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Device Story

SPEC Model M16 is a singly-encapsulated 192Iridium brachytherapy source consisting of a radioactive pellet sealed in a stainless steel capsule welded to a stranded stainless steel cable. Used in clinical oncology settings, the device is manipulated by a Best Medical High Dose Rate Remote Afterloader to deliver localized radiation therapy to tumors. The afterloader drives the source cable through applicators to the target site; the source emits photons (x-rays and gammas) to treat localized tumors. The device is operated by trained medical professionals (e.g., radiation oncologists, medical physicists) within a shielded environment. The output is ionizing radiation, which damages tumor cell DNA to inhibit growth. The device benefits patients by providing precise, high-dose localized radiation while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical testing (ANSI N43.6, ISO 2919), tensile load testing (up to 294 N), operational performance testing in the Best Medical Afterloader, and Monte Carlo dosimetric simulations following AAPM/ESTRO recommendations.

Technological Characteristics

192Iridium radioactive source; stainless steel capsule and 7x7 stranded stainless steel cable. Dimensions: 1.1 mm diameter x 4.8 mm length (capsule). Energy: 192Iridium (half-life 73.81 days) emitting characteristic photons (67 keV x-rays; 201, 311, 467, 603 keV gammas). Standards: ANSI N43.6 (Class C53211), ISO 2919, AAPM TG-43. Non-contact device; no sterilization required.

Indications for Use

Indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors in patients requiring high dose rate brachytherapy. Anatomical sites include cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast, and for treatment of sarcomas and intraoperative radiation therapy. May be used concurrently with or following external beam radiation therapy. Designed for use with the Best Medical High Dose Rate Remote Afterloader.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• SPEC Model M15 (K132969)

Submission Summary (Full Text)

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

June 19, 2015

Source Production and Equipment Co., Inc. % Ms. Kelly Richardt Regulatory and Quality Manager 113 Teal Street ST. ROSE LA 70087

Re: K150895

Trade/Device Name: SPEC Model M16 192Iridium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 26, 2015 Received: May 27, 2015

Dear Ms. Richardt:

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 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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K150895

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K150895

### Device Name

Source Production & Equipment Co., Inc. (SPEC) Model M16 192Iridium Brachytherapy Source

### Indications for Use (Describe)

Source Production & Equipment Co., Inc. (SPEC) Model M16 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Best Medical High Dose Rate Remote Afterloader. The Model M16 source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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K150895

Image /page/3/Picture/1 description: The image shows the word "spec" in a stylized font. To the right of the word is a radiation symbol. The letters are outlined in black, with a white fill. The radiation symbol is solid black.

# Section 5 510(k) Summary

### Section 807.92(a)

| (1) Submitter | Source Production & Equipment Co., Inc. |
|---------------|-----------------------------------------|
| | 113 Teal Street |
| | St. Rose, LA70087 |
| | Tel: [phone] |
| | Fax: [phone] |

| Establishment Registration No.: | 1000437833 |
|---------------------------------|------------|
|---------------------------------|------------|

Contact Person:

John J. Munro III Vice President e-mail: [e-mail]

- (2) Device Name:
Classification Name: Radionuclide Brachytherapy Source (892.5730) (90 KXK) Brachytherapy Source Assembly Common or Usual Name: Proprietary Name: SPEC Model M16

- (3) Legally Marketed Predicate Device:
Source Production & Equipment Co., Inc.Model M15, cleared under 510(k) number K132969 dated 02 January 2014

Description of SPEC Model M16192Iridium Brachytherapy Source: (4)

SPEC Model M16 is a singly-encapsulated 192 ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet. The pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

- (5) Intended Use
The intended use of SPEC Model M16 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

- Technological Characteristics: (6)
SPEC Model M16192 ridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 1921ridium.

Model M16192Iridium HDR Source R1

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Image /page/4/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the "c" is a radiation symbol. The word "spec" is outlined in black, and the radiation symbol is solid black. The image is in black and white.

| Technological | Source Production & Equipment Co.,<br>Inc. (SPEC) | |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | M16 192Iridium High Dose Rate<br>Brachytherapy Source | M15 192Iridium High Dose Rate<br>Brachytherapy Source |
| Design | The source consists of a solid 192Iridium<br>pellet (0.6 mm dia x 3.5 mm long) singly<br>encapsulated in stainless steel (1.1 mm<br>dia x 4.8 mm long) and welded to a 7x7<br>stranded stainless steel cable (1.1 mm dia<br>x 1800 mm long). | The source consists of a solid 192Iridium<br>pellet (0.6 mm dia x 3.5 mm long) singly<br>encapsulated in stainless steel (1.1 mm<br>dia x 4.8 mm long) and welded to a 7x7<br>stranded stainless steel cable (1.1 mm dia<br>x 2000 mm long). |
| Materials<br>Radionuclide<br>Encapsulation | 192Iridium<br>Stainless Steel | 192Iridium<br>Stainless Steel |
| Cable | Stainless Steel | Stainless Steel |
| Performance<br>Dosimetry (TG43)<br>Dose Rate Const ( $λ$ )<br>Anisotropy ( $ϕ$ av): | 1.11 cGy h-1 U-1<br>0.97 | 1.11 cGy h-1 U-1<br>0.97 |
| Sterility | This source assembly never directly<br>contacts the patient; sterility is not<br>required. | This source assembly never directly<br>contacts the patient; sterility is not<br>required. |
| Biocompatibility | This source assembly never directly<br>contacts the patient; biocompatibility<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from stainless steel, which is a<br>biocompatible material. | This source assembly never directly<br>contacts the patient; biocompatibility<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from stainless steel, which is a<br>biocompatible material. |
| Mechanical Safety | ANSI N43.6 Class C53211<br>Applied for Louisiana Registration | ANSI N43.6 Class C53211<br>Louisiana Sealed Source Registration<br>LA-0612-S-117-S |
| Chemical Safety | This source assembly never directly<br>contacts the patient; chemical safety<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from stainless steel, which<br>will not chemically react with body tissue. | This source assembly never directly<br>contacts the patient; chemical safety<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from stainless steel, which<br>will not chemically react with body tissue. |
| Energy Delivered | 192Iridium (half-life: 73.81 days) which<br>decays by beta emission and electron<br>capture with the emission of characteristic<br>photons and electrons. The betas and<br>electrons are absorbed by the stainless<br>steel wall of the source capsule. The<br>principal photon emissions are 67 keV x-<br>rays and 201, 311, 467, and 603 keV<br>gammas. | 192Iridium (half-life: 73.81 days) which<br>decays by beta emission and electron<br>capture with the emission of characteristic<br>photons and electrons. The betas and<br>electrons are absorbed by the stainless<br>steel wall of the source capsule. The<br>principal photon emissions are 67 keV x-<br>rays and 201, 311, 467, and 603 keV<br>gammas. |
| Compatibility with<br>Environment and<br>Other Devices | 192Iridium is a radioactive material and<br>should be strictly controlled. | 192Iridium is a radioactive material and<br>should be strictly controlled. |
| | The source should only be used following<br>the conditions and limitations specified by<br>the licensing authority (NRC or | The source should only be used following<br>the conditions and limitations specified by<br>the licensing authority (NRC or |
| | | |
| | AgreementState). | AgreementState). |
| | The source should be stored in a shielded | The source should be stored in a shielded |
| | container, either the remote afterloader<br>with which it is used or the transport<br>container in which it is delivered. | container, either the remote afterloader<br>with which it is used or the transport<br>container in which it is delivered. |
| | If any source cannot be accounted for, the<br>loss should be reported to the federal or<br>state licensing agency. | If any source cannot be accounted for, the<br>loss should be reported to the federal or<br>state licensing agency. |
| | Store at normal room temperature. | Store at normal room temperature. |
| | When disposal is indicated, radioactive<br>material should be transferred to an<br>authorized recipient, typically the source<br>supplier. Radioactive material should<br>never be disposed of in normal waste. | When disposal is indicated, radioactive<br>material should be transferred to an<br>authorized recipient, typically the source<br>supplier. Radioactive material should<br>never be disposed of in normal waste. |
| Where Used | This source should only be used within a<br>properly shielded enclosure designed to<br>maintain radiation dose rates outside the<br>enclosure within regulatory limits. | This source should only be used within a<br>properly shielded enclosure designed to<br>maintain radiation dose rates outside the<br>enclosure within regulatory limits. |
| Standards Met<br>Mechanical<br>Dosimetry | ANSI N43.6<br>AAPM TG-43 | ANSI N43.6<br>AAPM TG-43 |
| Electrical Safety | Not Applicable | Not Applicable |
| Thermal Safety | Not Applicable | Not Applicable |
| Radiation Safety | This 32 ridium source is radioactive, and<br>appropriate precautions must be taken<br>during handling to minimize radiation<br>exposure to personnel. Personnel<br>monitoring is required. | This 192 ridium source is radioactive, and<br>appropriate precautions must be taken<br>during handling to minimize radiation<br>exposure to personnel. Personnel<br>monitoring is required. |
| | This source should only be used within a<br>properly shielded enclosure designed to<br>maintain radiation dose rates outside the<br>enclosure within regulatory limits. | This source should only be used within a<br>properly shielded enclosure designed to<br>maintain radiation dose rates outside the<br>enclosure within regulatory limits. |
| | In circumstances where emergency<br>operations must be performed within<br>protective barriers, the operator should<br>use proper applicators, maintain safe<br>working distances and work as rapidly as<br>safely possible to minimize radiation<br>exposure. | In circumstances where emergency<br>operations must be performed within<br>protective barriers, the operator should<br>use proper applicators, maintain safe<br>working distances and work as rapidly as<br>safely possible to minimize radiation<br>exposure. |

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## Section 807.92(b)

#### Nonclinical Tests (1)

## Physical Testing

The Model M16 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO)

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Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000.

Prototype sources were subjected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. This is equivalent to the physical testing of the predicate device.

## Tensile Testing

Prototype sources were subjected to a tensile load of 294 N (66 lb) without failure. The maximum force that can be applied by the Best Medical Afterloader is 16.5 N (3.7 Ib). Therefore, this test load was more than 17 times the maximum force that can be applied by the Best Medical Afterloader.

In addition, prototypes were subjected to a series of tensile fatigue tests consisting of:

- a tensile load of 107 N (24 lb), which is more than 6 times the maximum force . than can be applied to the cable by the Best Medical Afterloader
- . ten sequential applications of a tensile load of in excess of 53 N (12 lbs) which is more than 3 times the maximum load that can be applied by the Best Medical Afterloader, and then
- . subjected to a tensile load tensile load of 294 N (66 lb) without failure. This tensile load was more than 17 times the maximum force that can be applied by the Best Medical Afterloader.

It is concluded that the tensile strength of this source assemble is sufficient for its intended application. This is equivalent to or better than the tensile testing of the predicate device.

## Operational Testing

A prototype source assembly was subjected to a performance test in aBest Medical Afterloader. consisting of driving the source cable through a series of "S" and "U" curves with a variety of radii which simulate the various pathways of applicators used with the Best Medical Afterloader. The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M16 source assembly.

This is equivalent to the physical testing of the predicate device.

## Dosimetry

The dose distribution around the Model M16 source was calculated by Monte Carlo simulation in accordance with the recommendations of the American Association of Physicists in Medicine and the European Society for Therapeutic Radiation Oncology. TThis is equivalent to the dosimetry of the predicate device.

#### (2) Clinical Tests

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Not Applicable

#### (3) Conclusions

The results of the nonclinical physical, tensile, operational tests and the dosimetric analysis, demonstrate that the SPEC Model M16 High Dose Rate Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate device, SPEC Model M15 High Dose Rate Brachytherapy Source.

¹ Perez-Calatayud J, Ballester F, Das RK, Dewerd LA, Ibbott GS, MeigooniAS, Ouhib Z, Rivard MJ, Sloboda RS, Williamson JF, Dose calculation for photon-emitting brachytherapy sources with average energy higher than 50keV: report of the AAPM and ESTRO, Med Phys. 2012 May;39(5):2904-29