(49 days)
OptiStrand103 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, breast, cervix, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiStrand103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
OptiStrand 103 implants are OptiSource™ seeds (#K040766) linked together with a spacer or spacers to create a multi-seed sourcetrain.
This 510(k) pertains to OptiStrand™, an interstitial implant used in brachytherapy. The documentation provided does not include the level of detail requested for acceptance criteria, device performance, and study methodology typically found in a comprehensive clinical or performance study report.
Based on the provided information, the 510(k) submission is a traditional submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance study with detailed acceptance criteria and statistical analysis as would be done for novel devices or those requiring a PMA.
Here's a breakdown of the available information and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the given 510(k) summary and FDA clearance letter. A 510(k) submission for this type of device (radionuclide brachytherapy source) often relies on demonstrating technical and performance equivalence to a legally marketed predicate device rather than setting new, specific performance acceptance criteria for clinical outcomes. The performance characteristics would typically relate to source strength, radiation output, physical dimensions, and biocompatibility, which are assumed to be equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. As this is a traditional 510(k) for a device like a brachytherapy source, a "test set" in the context of evaluating diagnostic accuracy (e.g., for AI) is not applicable. The evaluation would have focused on engineering and physical performance characteristics.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. This concept of "ground truth" established by experts is relevant for diagnostic accuracy studies, which are not detailed here.
4. Adjudication Method:
This information is not provided. Adjudication methods are typically used in studies where multiple readers or experts provide assessments and a consensus is needed to establish ground truth or resolve discrepancies, which is not applicable in the context of this device's 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI algorithms in comparison to human readers. This device is a therapeutic brachytherapy source, not a diagnostic tool, so such a study would not be relevant.
6. Standalone (Algorithm Only) Performance Study:
This information is not provided. A standalone algorithm performance study is relevant for AI-powered diagnostic devices. This device is a physical therapeutic implant, so this type of study is not applicable.
7. Type of Ground Truth Used:
This information is not provided. Ground truth (e.g., pathology, outcomes data) is typically established for diagnostic or prognostic devices. For a brachytherapy source, the "ground truth" relates to its physical and radioactive properties (e.g., accuracy of dose delivery, source strength, physical integrity), which are evaluated through engineering tests and quality control, not typically through clinical "ground truth" as might be understood for a diagnostic algorithm.
8. Sample Size for the Training Set:
This information is not provided. The concept of a "training set" is relevant for machine learning or AI algorithms. This device is a physical medical device, not an AI product.
9. How Ground Truth for the Training Set Was Established:
This information is not provided for the same reasons as point 8.
Summary of what can be ascertained from the provided document regarding acceptance criteria and study:
The 510(k) filing for OptiStrand™ seeks market clearance based on substantial equivalence to a previously cleared predicate device. This means the manufacturer demonstrated that the new device is as safe and effective as a legally marketed device that is not subject to PMA.
The core of the "study" for a device like OptiStrand™ would involve demonstrating that:
- Materials: The materials used are equivalent to the predicate or are biocompatible.
- Design and Dimensions: The physical dimensions and design of the seeds and spacers are equivalent to the predicate or meet established standards.
- Radioactive Properties: The radionuclide and its activity levels are consistent with established standards for brachytherapy sources and equivalent to the predicate (OptiSource™ seeds #K040766). This would involve physical measurements and calculations.
- Sterility and Packaging: The device can be consistently sterilized and packaged to maintain sterility until use.
- Manufacturing Quality: The manufacturing process ensures consistent quality and adherence to specifications.
The FDA's clearance letter (K043336) states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced within to reviewed the device is substantially equivalent (for the indications for use stated in above und nave deegally marketed predicate devices marketed in interstate commerce prior to the cleasars) to regally that the Medical Device Amendments, or to devices that have been May 20, 1770, the classicans of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordantes approval application (PMA)." This confirms that the basis for approval was substantial equivalence, and therefore, a detailed clinical study with the specified metrics for AI devices was not performed or required. The "study" was a demonstration of equivalence in design, materials, and intended use as assessed through documentation and potentially bench testing.
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JAN 2005
| 2 December 2004 | CONFIDENTIAL | Page 16 of 16 | |
|---|---|---|---|
| Title: | Premarket Notification: Traditional 510(k) – OptiStrand™ |
510(k) SUMMARY
| Applicant /Manufacturing Site: | IBt s.a. |
|---|---|
| Zone Industrielle C | |
| 7180 Seneffe - Belgium | |
| Tel: | (+32) 64 / 520 811 |
| Fax: | (+32) 64 / 520 801 |
| Establishment Registration Number: | 9031509 (IBt s.a.) |
| Contact Person IBt s.a.: | Sylviane Berger, Management Representative |
| E-mail: | sberger@brachytherapy.be and FDA@ibt4seeds.com |
| Official Correspondent: | |
| IBt, Inc. | |
| 6000 Live Oak Parkway, Suite 107 | |
| Norcross, GA 30093 | |
| Tel: | (770) 582 0662 |
| Fax: | (770) 582 0657 |
| Establishment Registration Number: | 9035105 (IBt, Inc.) |
| Contact Person IBt, Inc.: | Ruth Feicht, Regulatory |
| E-mail: | rfeicht@ibt4seeds.com and FDA@ibt4seeds.com |
| Device Information | |
|---|---|
| Trade Name: | OptiStrand 103 (OptiStrand™ is a Trademark of IBt s.a.) |
| Model Number: | 1032S |
| Common Name of Device | Sealed Source; seed; interstitial implant |
| Description: | OptiStrand 103 implants are OptiSource™ seeds (#K040766) linked together with a spacer or spacers to create a multi-seed sourcetrain. |
| Type of 510(k) Submission: | Traditional |
|---|---|
| ----------------------------------- | ------------- |
| Classification Information | |
|---|---|
| Classification: | Radionuclide Brachytherapy Source |
| Class of Device: | 21 CFR 892.5730, Class II |
| Product Code: | 90-KXK |
Intended Use
OptiStrand103 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, breast, cervix, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiStrand103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
IBt, s.a. % Ms. Ruth Feicht Regulatory IBt, Inc. 6000 Live Oak Parkway, Suite 107 NORCROSS GA 30093
Re: K043336 Trade/Device Name: OptiStrand103 (OptiStrand™ is a Trademark of IBt, s.a.) Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: December 2, 2004 Received: December 8, 2004
Dear Ms. Feicht:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced within to reviewed the device is substantially equivalent (for the indications for use stated in above und nave deegally marketed predicate devices marketed in interstate commerce prior to the cleasars) to regally that the Medical Device Amendments, or to devices that have been May 20, 1770, the classicans of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordantes approval application (PMA). You may, therefore, market the do not require approvisions 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 n your do rio result subject to such additional controls. Existing major regulations affecting your Apple 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 I our an bailers and and and 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) (21 CFR Part 807), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the mo premarket notification. THE FDA Inding of Sacsantal vice 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 If you desire specific advice for your device of our lasting organized on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation on entired, "Albertation on your responsibilities under the Act from the 807.97). You may outlair other general missistance at its toll-free number (800) Division of Small Manufacturers, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
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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510(k) Number (if Known):
Device Name: OptiStrand103
Indications For Use:
OptiStrand103 implants are indicated for interstitial implantation of select Optiotrand - implants are indiosensitivity. They are used either localized tumors with fow to firs such as those of the head, lung, neck, as primary treatment for tumble eden as thesectable tumors, or for residual pancreast, breast, cervix, prostate, and unresocials/ callistics are ulsease anch exolon of the prither with or at the completion of other treatment Indicated for use conourront wan or adiation therapy or chemotherapy.
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
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Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________
Nancy Gordon
(Division Sizn-Off) Division of Reproductive, Abdominal, and Radiological Devi $10(k) Number
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§ 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.