(109 days)
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.
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.
The provided text describes a 510(k) submission for a medical device called RAPID Strand Rx. The submission is not for a new device requiring extensive performance studies but for modifications to an already cleared device. Specifically, this Special 510(k) is for:
- Addition of a loading services provider.
- Addition of bone wax needle plugging material.
- Removal of a seed design.
The central claim is that the modified device is "substantially equivalent" to its predicate device (RAPID Strand Rx, K063177). Therefore, the study described focuses on demonstrating this substantial equivalence rather than proving new performance criteria in a clinical setting.
Given this context, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, MRMC studies, standalone performance with AI, training set details) are not applicable to this type of submission. This 510(k) is not about evaluating a diagnostic algorithm or a device with measurable performance metrics in the way those questions imply.
Here's an attempt to answer based on the available information:
-
A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Substantial Equivalence to Predicate Device (K063177) Medi-Physics Inc. concluded that the device is substantially equivalent to the predicate device. Safety and Effectiveness Medi-Physics Inc. concluded that the device is safe and effective for its intended use. Technological Characteristics of Bone Wax Formulation Subject to design controls and risk management. All identified hazards have been sufficiently mitigated. All results are acceptable. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable (N/A). This 510(k) is for modifications to an existing device and relies on engineering assessments and substantial equivalence, not a clinical test set with patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable (N/A). Ground truth as typically defined for a diagnostic study is not established here. The assessment is based on design controls and risk management for the modifications. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable (N/A). No test set requiring expert adjudication is described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable (N/A). This device is a radionuclide brachytherapy source, not an AI-powered diagnostic tool, and no MRMC study is mentioned or relevant to this submission type. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable (N/A). This is not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the established safety and performance of the predicate device, against which the modified device's technological characteristics (specifically the bone wax formulation) were assessed through design controls and risk management. It's not a clinical ground truth but rather an engineering and regulatory "ground truth" of substantial equivalence. -
The sample size for the training set
Not applicable (N/A). There is no training set for an algorithm mentioned. -
How the ground truth for the training set was established
Not applicable (N/A). There is no training set for an algorithm mentioned.
{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
{4}------------------------------------------------
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)
Page 1 of
§ 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.