(90 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, radiation safety, and time efficiency, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
Yes.
The device is used to deliver a radioactive source for the treatment of localized tumors, directly contributing to therapy.
No
The device is used for delivering radioactive sources for brachytherapy treatment, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (seed magazine, stainless steel shield, Polyglactin 910 spacer) and functional testing related to material properties and radiation shielding, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "loading a radionuclide brachytherapy source into the Indigo Prostate Seeding Needles for prostate brachytherapy" and "to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors." This describes a therapeutic procedure involving the delivery of radiation directly into the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details components used for handling and delivering radioactive seeds and spacers within the body. This aligns with a therapeutic device, not a diagnostic one.
- 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 based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate a therapeutic intervention (brachytherapy).
N/A
Intended Use / Indications for Use
The Indigo Prostate Seeding Needle Cartridge System is a single use, disposable system which is intended as a convenience and radiation safety device for the purpose of loading a radionuclide brachytherapy source into the Índigo Prostate Seeding Needles for prostate brachytherapy.
The Indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors which are of low to moderate radiosensitivity.
Product codes
90 KXK
Device Description
The Indigo Prostate Seeding Needle Cartridge System consists of two main components, a single use, disposable seed magazine with a stainless steel shield and a Polyglactin 910 (PG910) absorbable spacer, which is a small cylindrical pellet utilized to provide space between the radionuclide seeds as they are implanted into the body. Both devices are intended to be used only in conjunction with Indigo Prostate Seeding Needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate gland
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
Nonclinical Tests: Functional testing of the cartridge material and compression testing of the spacers were performed post-autoclaving to ensure the durability and functionality of the devices. A time study and radiation scanning were done to ensure that the cartridge system reduces the physicist's barriers (time and radiation exposure) for the preloaded seed delivery technique.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
PPENDIX XIV
510(k) SUMMAR
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 Indigo Prostate Seeding Needle Cartridge System.
Submitter: Índigo Medical, Inc. 10123 Alliance Road Cincinnati, Oh 45242 Telephone : 513-786-7987 Fax : 513- 483-3410 Jacquelyn A. Hughes, RAC Contact Person :
Device Name :
| Trade Name: | Índigo Prostate Seeding Needle Cartridge System |
|---|---|
| Common Name: | Accessory to applicator and accessory to |
| radionuclide bracytherapy source | |
| Proprietary Name: | Índigo Prostate Seeding Needle Cartridge System |
| Classification Name: | System, applicator, radionuclide, manual & |
| Source, brachytherapy, radionuclide (accessory to) | |
| Prepared: | June 30, 1999 |
Date Prepared:
Predicate Device: The predicate device to the Indigo Prostate Seeding Needle Cartridge is the Mick seed magazine used in conjunction with the Mick ™ 200-TP Applicator cleared under 510(k) K890341. The predicate devices to the Indigo Seed Spacer are I-125 Rapid Strand™, cleared under K940632, and LOOK, Inc. Spacing Material, 510(k) number unknown.
Device Description: The Indigo Prostate Seeding Needle Cartridge System consists of two main components, a single use, disposable seed magazine with a stainless steel shield and a Polyglactin 910 (PG910) absorbable spacer, which is a small cylindrical pellet utilized to provide space between the radionuclide seeds as they are implanted into the body. Both devices are intended to be used only in conjunction with Indigo Prostate Seeding Needles.
1
Intended Use: The Indigo Prostate Seeding Needle Cartridge System is a single use, disposable system which is intended as a convenience and radiation safety device for the purpose of loading a radionuclide brachytherapy source into the Índigo Prostate Seeding Needles for prostate brachytherapy.
Indications: The Indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors which are of low to moderate radiosensitivity.
Comparison of Technological Characteristics: The Indigo Prostate Seeding Needle Cartridge is a single use, disposable device for delivering radionuclides into a manual applicator preoperatively while the Mick magazines are reusable and single use, disposable devices for delivering radionuclides into a manual applicator intraoperatively.
The Indigo Seed Spacer is an absorbable pellet of PG 910 intended to maintain 1 cm spacing between seeds of either I-125 or Pd-103 when delivered by a preloaded seeding needle into the prostate. The I-125 Rapid Strand™ is a device of braided, absorbable VICRYL® Suture imbedded with I-125 seeds at 1 cm intervals center to center for delivery by preloaded seeding needle into the prostate.
Nonclinical Tests: Functional testing of the cartridge material and compression testing of the spacers were performed post-autoclaving to ensure the durability and functionality of the devices. A time study and radiation scanning were done to ensure that the cartridge system reduces the physicist's barriers (time and radiation exposure) for the preloaded seed delivery technique.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 OCT
Jacquelyn A. Hughes Regulatory Affairs Manager Indigo Medical Inc. 10123 Alliance Road Cincinnati, OH 45242
Re:
K992262 Indigo Prostate Seeding Needle Cartridge System Dated: July 2, 1999 Received: July 6, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Ms. Hughes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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. Iising 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 requlation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510 (k) Number (if known) : _ K 992262
Device Name : İndigo Prostate Seeding Needle Cartridge System
Indications for Use : The Indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors which arc of low to moderate radiosensitivity.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ernest A. Segerstrom
(Division Sign-off) Division of Reproductive, Abdominal, ENT & Radiological Devices
510(k) number K992262
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use