SPEC Model M23

K161396 · Source Production and Equipment Co., Inc. · KXK · Aug 17, 2016 · Radiology

Device Facts

• Record ID: K161396
• Device Name: SPEC Model M23
• Applicant: Source Production and Equipment Co., Inc.
• Product Code: KXK · Radiology
• Decision Date: Aug 17, 2016
• 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 M23 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Device Story

SPEC Model M23 is a singly-encapsulated Ytterbium-169 brachytherapy source; consists of solid Ytterbium-169 oxide pellets sealed in a stainless steel capsule; attached to a stranded stainless steel cable for manipulation by remote afterloading systems. Used in clinical settings (e.g., oncology departments) by radiation oncologists and medical physicists. Device delivers high-dose-rate (HDR) radiation to localized tumors; input is the radioactive isotope; output is photon/electron emission. Healthcare providers use the source within a remote afterloader to deliver precise radiation doses to target tissues; facilitates tumor treatment while minimizing exposure to healthy tissue. Benefits include targeted radiation therapy for various cancers.

Clinical Evidence

Bench testing only. No clinical data provided. Physical testing performed per ANSI N43.6-2007 and ISO 2919-2012, achieving classification C53211. Tensile testing confirmed failure loads (85 N) significantly exceeding maximum forces applied by the Varian GammaMed Plus Afterloader (16 N). Operational testing confirmed the source assembly successfully negotiated simulated 'S' and 'U' curved pathways without damage.

Technological Characteristics

Radioactive Ytterbium-169 source; solid oxide pellets; stainless steel encapsulation; stranded stainless steel cable. Energy source: radioactive decay (electron capture, photon/electron emission). Dimensions: 0.9 mm diameter capsule. Standards: ANSI N43.6, ISO 2919, AAPM TG-43. Not patient-contacting; no sterilization required. Standalone component for remote afterloader systems.

Indications for Use

Indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. Used as primary treatment for anatomical sites including cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast, and for sarcomas and intraoperative radiation therapy. May be used concurrently with or following external beam radiation therapy.

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

• Implant Sciences Corp. Model HDR-4140 (K042864)

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

August 17, 2016

Source Production and Equipment Co., Inc. % Ms. Kelley Richardt Regulatory and Ouality Manager 113 Teal Street SAINT ROSE LA 70087

Re: K161396

Trade/Device Name: Source Production & Equipment Co., Inc. Model M23 169Ytterbium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 16, 2016 Received: May 19, 2016

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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K161396

#### Device Name

Source Production & Equipment Co., Inc. Model M23 169Ytterbium Brachytherapy Source

#### Indications for Use (Describe)

Source Production & Equipment Co., Inc. (SPEC) Model M23 Source Assembly, with individual activity up to 27 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This 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)

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section 5 510(k) Summary

Section 807.92(a)

- Submitter Source Production & Equipment Co., Inc. Tel: [phone] (1) 113 Teal Street 504.467.7685 Fax: St. Rose, LA 70087 Establishment Registration No : 1000437833 Contact Person: John J. Munro III Vice President e-mail: [e-mail]
- Device Name: (2)

| Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) |
|-----------------------|-------------------------------------------------------|
| Common or Usual Name: | Brachytherapy Source Assembly |
| Proprietary Name: | SPEC Model M23 |

- (3) Legally Marketed Predicate Device:
Implant Sciences Corp. Model HDR-4140, cleared under 510(k) number K042864 dated 06 Jan 2005 as described in Section 12

- Description of SPEC Model M23 169Ytterbium Brachytherapy Source: (4)
SPEC Model M23 is a singly-encapsulated 168 ftterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive 160Ytterbium Oxide pellets. The pellets are 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 M23 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

- (6) Technological Characteristics:
SPEC Model M23 169Ytterbium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 168Ytterbium.

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| Technological<br>Characteristic | Source Production & Equipment Co.,<br>Inc. (SPEC)<br>M23 169Ytterbium High Dose Rate<br>Brachytherapy Source | Implant Sciences Corp.<br>HDR-4140 169Ytterbium High Dose Rate<br>Brachytherapy Source |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of solid 169Ytterbium<br>Oxide pellets (Configuration H: 0.6 mm<br>dia x 3.5 mm long; Configuration P: 0.6<br>mm dia x 2.0 mm long)) singly<br>encapsulated in stainless steel<br>(Configuration H: 0.9 mm dia x 4.8 mm<br>long; Configuration P: 0.9 mm dia x 3.3<br>mm long) and welded to a 7x7+4 stranded<br>stainless steel cable (0.9 mm dia x 2100<br>mm long). | The source consists of solid 169Ytterbium<br>pellets (0.65 mm dia x 4.0 mm overall<br>length) doubly encapsulated. The inner<br>capsule (0.8 mm dia x 4.5 mm lg) is<br>titanium and the outer capsule (0.98 mm<br>dia x 5.9 mm long) is stainless steel. The<br>outer capsule is welded to a 7x7 stranded<br>stainless steel cable (0.9 mm dia x 2100<br>mm long). |
| Materials<br>Radionuclide<br>Encapsulation | 169Ytterbium<br>Stainless Steel | 169Ytterbium<br>Titanium & Stainless Steel |
| Cable | Stainless Steel | Stainless Steel |
| Performance<br>Dosimetry (TG43)<br>Dose Rate Const (λ)<br>Anisotropy (φav): | Configuration H Configuration P<br>1.17 cGy h-1 U-1<br>1.18 cGy h-1 U-1<br>0.94<br>0.94 | 1.18 cGy h-1 U-1<br>0.94 |
| 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 C64212<br>Applied for Louisiana Registration | ANSI N43.6 Class C64212 |
| 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 is<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 is<br>will not chemically react with body tissue. |
| Energy Delivered<br>Compatibility with<br>Environment and | 169Ytterbium (half-life: 32.02 days) which<br>decays by electron capture with the<br>emission of characteristic photons and<br>electrons. The electrons are absorbed by<br>the titanium and stainless steel walls of<br>the source encapsulation. The principal<br>photon emissions are 50 and 58 keV x-<br>rays and a 63, 94, 111, 131, 177, 198,<br>260 and 308 keV gammas.<br>169Ytterbium is a radioactive material and<br>should be strictly controlled. | 169Ytterbium (half-life: 32.02 days) which<br>decays by electron capture with the<br>emission of characteristic photons and<br>electrons. The electrons are absorbed by<br>the titanium and stainless steel walls of<br>the source encapsulation. The principal<br>photon emissions are 50 and 58 keV x-<br>rays and a 63, 94, 111, 131, 177, 198,<br>260 and 308 keV gammas.<br>169Ytterbium is a radioactive material and<br>should be strictly controlled. |
| Other Devices | | |
| | The source should only be used following<br>the conditions and limitations specified by<br>the licensing authority (NRC or Agreement<br>State). | The source should only be used following<br>the conditions and limitations specified by<br>the licensing authority (NRC or Agreement<br>State). |
| | The source should be stored in a shielded<br>container, either the remote afterloader<br>with which it is used or the transport<br>container in which it is delivered. | The source should be stored in a shielded<br>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 169Ytterbium source is radioactive,<br>and appropriate precautions must be<br>taken during handling to minimize<br>radiation exposure to personnel.<br>Personnel monitoring is required. | This 169Ytterbium source is radioactive,<br>and appropriate precautions must be<br>taken during handling to minimize<br>radiation exposure to personnel.<br>Personnel 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 M23 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) 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 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. Th3 testing performed is equivalent to the physical testing of the predicate device.

#### Tensile Testing

Prototype sources were subjected to a tensile load to failure with the minimum failure load of 85 N (19 lb). The maximum force that can be applied by the Varian GammaMed Plus Afterloader is 16 N (3.6 lb). Therefore, this test load was more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.

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

- a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum ● force than can be applied to the cable by the Varian GammaMed Plus Afterloader
- ten sequential applications of a tensile load of in excess of 16 N (3.6 lbs) which is . more than the maximum load that can be applied by the Varian GammaMed Plus Afterloader, and then
- a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum . force than can be applied to the cable by the Varian GammaMed Plus Afterloader
- . and finally a tensile load to failure of each of the welds of the source assembly, where the the minimum failure load was 84 N (19 lb) which is more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.

It is concluded that 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 curved pathway performance test 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 GammaMed Plus Afterloader. The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M13 source assembly.