(109 days)
Not Found
No
The 510(k) summary describes a radioactive seed implant for cancer treatment and modifications to its loading and materials. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for the permanent interstitial implantation into selected localized tumors for treatment, which is a therapeutic purpose.
No
Explanation: The device is indicated for permanent interstitial implantation in localized tumors for treatment, not for diagnosis.
No
The device description explicitly mentions "permanent interstitial implantation" and "addition of bone wax needle plugging material," indicating a physical implant and material, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "permanent interstitial implantation of selected localized tumors." This describes a therapeutic device used within the body to treat cancer, not a device used outside the body to diagnose a condition based on analyzing biological samples.
- Device Description: The description talks about "interstitial implantation," "seed design," and "needle plugging material," all of which are consistent with a brachytherapy device used for internal radiation treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand TM Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external bear or adiation therapy or chemotherapy.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
This Special 510(k) is for the addition of a loading services provider, addition of bone wax needle plugging material and removal of a seed design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5730 Radionuclide brachytherapy source.
(a)
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.(b)
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.
0
510(k) SUMMARY Date Prepared: 04 Sep 2012
DEC 2 8 2012
1. Company Name and Address
Medi-Physics Inc. dba GE Healthcare 3350 N Ridge Avenue Arlington Heights, IL 60004
× 122764
Contact Person:
David Risley Director, US Regulatory Telephone (direct dial): 609-514-6489 Fax #: 609-514-6695 David.Risley@ge.com
2. Device Name
Proprietary Name: RAPID Strand Rx Common Name: Radionuclide Brachytherapy Source
3. Classification
Radionuclide Brachytherapy Source has been classified by the Reproductive, Abdominal, and Radiological Devices Panel as Class II, 90-KXK. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Radionuclide Brachytherapy Source (21 CFR 892.5730).
4. Predicate Device
Medi-Physics Inc. RAPID Strand Rx This 510(k), K063177, received FDA clearance on November 30, 2006.
5. Device Description
This Special 510(k) is for the addition of a loading services provider, addition of bone wax needle plugging material and removal of a seed design.
Medi-Physics Inc. has concluded that the device is substantially equivalent to the predicate device (RAPID Strand Rx, K063177), and is safe and effective for its intended use.
1
Indications for use for RAPID Strand Rx:
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand TM Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external bear or adiation therapy or chemotherapy.
Summary of Technological Characteristics Compared to Predicate Device
The product has the same intended use and fundamental scientific technology as the predicate device, RAPID Strand Rx (K063177).
The technological characteristics of the bone wax formulation were subject to design controls and risk management. All identified hazards have been sufficiently mitigated. A summary of results is enclosed. All the results are acceptable.
Conclusion:
Based on the above, Medi-Physics Inc. believes the RAPID Strand Rx is is substantially equivalent to the predicate device, and is safe and effective for its intended use.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 28, 2012
C/O Mr. David Risley Director, Ouality, US Regulatory Medi-Physics Inc. dba GE Healthcare 3350 N. Ridge Avenue ARLINGTON HEIGHTS, IL 60004
Re: K122764
Trade/Device Name: RAPID Strand Rx Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 18, 2012 Received: December 19, 2012
Dear Mr. Risley:
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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you desire operities and AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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 note the regalations 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 I ou may obtain other generational 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,
Janine M. Morris 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): K122764
Rapid Strand Rx Device Name:
Indications for Use:
RAPID Strand The Rx is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary turnor.
RAPID Strand The Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
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 In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)
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