(90 days)
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.
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.
The provided text, K992262, is a 510(k) summary for the Indigo Prostate Seeding Needle Cartridge System. This document describes a medical device and its predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies.
The "Nonclinical Tests" section mentions functional testing and a time study, but these are engineering/design validation tests and not a clinical study proving performance against predefined acceptance criteria for diagnostic accuracy or clinical efficacy. The device is an accessory for brachytherapy source delivery, not a diagnostic or AI-powered device that would typically have the requested types of performance studies.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided document.
Here's a breakdown of what can be extracted from the document, though it doesn't align with the requested format:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided document. The document describes non-clinical tests (functional testing of cartridge material, compression testing of spacers, time study, and radiation scanning) but does not provide specific acceptance criteria or an aggregated "reported device performance" table in the context of clinical outcomes or diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided document. The document describes non-clinical tests, not clinical studies with test sets.
3. 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 and not available. This device is an accessory for delivering brachytherapy sources, not an AI or diagnostic device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not available.
5. 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 and not available. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not available. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable and not available. The "Nonclinical Tests" relate to device durability, functionality, time efficiency, and radiation exposure, not clinical ground truth for diagnosis/prognosis.
8. The sample size for the training set
- Not applicable and not available. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable and not available.
Summary of available non-clinical test information from the document:
-
Nonclinical Tests Performed:
- Functional testing of the cartridge material (post-autoclaving)
- Compression testing of the spacers (post-autoclaving)
- Time study (to ensure reduction in physicist's barriers for preloaded seed delivery)
- Radiation scanning (to ensure reduction in physicist's barriers for preloaded seed delivery)
-
Purpose of these tests: To ensure the durability and functionality of the devices and to demonstrate that the cartridge system reduces the physicist's barriers (time and radiation exposure) for the preloaded seed delivery technique.
Therefore, while non-clinical tests were performed to support the 510(k) clearance, the provided document does not contain the specific type of clinical performance study data requested for AI or diagnostic devices.
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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 toradionuclide 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.
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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.
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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
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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
§ 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.