(53 days)
Not Found
No
The summary describes a physical accessory device for brachytherapy and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used in brachytherapy procedures to facilitate the introduction of radionuclide seeds into the body, which is a therapeutic intervention for medical conditions.
No
The device description clearly states its purpose as an "accessory in brachytherapy procedures" and for use "to facilitate the introduction of radionuclide seeds and spacers into the body." These functions are interventional and therapeutic, not diagnostic.
No
The device description explicitly states it is a physical component ("synthetic absorbable polymer or copolymer material, braided and non-braided") used in brachytherapy procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory in brachytherapy procedures, used to facilitate the introduction of radionuclide seeds into the body. This is a therapeutic procedure performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a physical device (strand and spacers) used for placement within the body. This aligns with a medical device used in a therapeutic procedure, not a reagent or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or copolymer matcrial, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue or organ tissue
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.
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BEST MEDICAL INTERNATIONAL, INC.
AUG - 4 2006
VII. Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed Best Medical International, Best Strand component device.
| Manufacturer: | Best Medical International, Inc.
7643 Fullerton Road
Springfield, VA 22153
Phone: (703) 451-2378
Fax: (703) 451-4736. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Phelan
Dir, Quality and Regulatory Affairs |
Device Name:
| Trade Name: | Best Strand |
|---|---|
| Common Name: | Brachytherapy Synthetic, Absorbable Placement Sleeve |
| Accessory to seed and spacer components. | |
| Proprietary name: | Best Strand |
| Classification: | Radionuclide brachytherapy source (accessory to) |
| Date Prepared: | June 8, 2006 |
Predicate Device: The predicate device to the Best Medical, Bcst Strand accessory device is the CP Medical CARRJER SLEEVE accessory device (K034062), and the I-125 Rapid Strand's accessory Sleeve (K940632 and K010821).
Device Description: The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or copolymer matcrial, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.
Intended Use: Best Medical International's synthetic, absorbable placement sleeve accessory (Best Strand) is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during
1
BEST MEDICAL INTERNATIONAL, INC.
Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component.
Indications: The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
Comparison of Technological Characteristics: The proposed device, the Best Strand is comprised of a synthetic absorbable suture material and is intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers. Similarly, the predicate device is composed of synthetic absorbable suture material intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The HHS name is written around the caduceus in a circular fashion.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 4 2006
Mr. Michael J. Phelan Best Medical International, Inc. 7643 Fullerton Road SPRINGFIELD VA 22153
Re: K061638
Trade/Device Name: Best Strand, Best Spacer Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: June 8, 2006 Received: June 14, 2006
Dear Mr. Phelan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a bold font. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
Protecting and Promoting Public Health
3
Page 2 -
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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 877, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qtial of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with aration. The FDA finding of substantial equivalence of your device to a legally premainer noticated device results in a classification for your device 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 n you dear office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Nancy C. Hogdon
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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BEST MEDICAL INTERNATIONAL, INC.
Appendix 2
Indications for Use Form
510 (k) Number: K061638
(1) Device Name(s): Best Strand, Best Spacer
Indications For Use:
The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Usc
David R. Lyppman
13 Revised 7/31/2006
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number ...
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