(176 days)
as a palliative treatment for malignant neoplasms in the biliary tree
IntraTherapeutics. Inc. device is a balloon expandable stainless steel stent with an open lattice design. The ITI Stent is provided unmounted to be manually crimped onto a noncompliant PTA balloon catheter of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The provided text is related to a 510(k) submission for a medical device called the "ITI Stent," a biliary catheter. This documentation focuses on establishing substantial equivalence to a predicate device based on material, intended use, and technological characteristics, supported by bench testing. This type of submission does not typically involve clinical trials with human subjects, AI algorithms, or detailed performance metrics as would be required for software-as-a-medical-device (SaMD) or clinical diagnostic devices.
Therefore, many of the questions you've asked (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, AI assistance) are not applicable to this type of device submission as described in the provided text. The device is a physical medical device (a stent), not a diagnostic algorithm or AI software.
Here's a breakdown of what can be extracted or inferred from the provided information, and where the information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Noncytotoxic |
| Pyrogenicity | Nonpyrogenic (tested on a lot-to-lot basis) |
| Material | Identical to predicate (316L stainless steel) |
| Technological Characteristics | Identical to predicate (balloon expandable, open lattice, laser-cut slots, cleaned, electro-polished) |
| Performance (Bench Tests) | "Comparison bench tests regarding performance characteristics were performed... to demonstrate equivalency." (Specific quantitative performance metrics are not detailed in the summary.) |
| Sterilization | Ethylene oxide sterilized (Predicate: CO60) |
| Delivery Mechanism | Provided unmounted for manual crimping (Predicate: also unmounted, or premounted; predicate offers separate crimping tool, ITI does not.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The study described involves bench tests on the device itself, not clinical data or patient test sets. Therefore, there is no "sample size" of patients or data, nor data provenance in the context of clinical studies.
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. As this is a physical medical device and not a diagnostic system, there is no "ground truth" to be established by experts from patient data in the context of this 510(k) summary. The "ground truth" for the device's characteristics would be established by engineering specifications and material standards, verified through testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there is no clinical test set requiring expert interpretation, no adjudication method is relevant.
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. This is a physical medical device (stent), not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering specifications, material science standards, and established bench testing protocols designed to assess mechanical properties, biocompatibility, and pyrogenicity. These are compared to the predicate device to demonstrate substantial equivalence.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
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510(k) Summary (Page 1 of 2)
Product Name: ITI Stent Common Name: Biliary catheter
| Submitter's Name: | IntraTherapeutics, Inc651 Campus DriveSt. Paul, MN 55112 |
|---|---|
| Official Contact: | Amy Peterson |
my Peters Official Contact: Vice President RA and QA Tel. 612-697-2076 Fax 612-697-2085
Summary Preparation Date: January 23, 1998
This summary is provide in compliance with section 513(D(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.
The product trade and common name are ITI Stent and biliary catheter, respectively. This is a Class II product classified under 21 CFR §8768.5010 as a biliary catheter and accessories. Substantial equivalence is claimed to Cordis Corporation, legally marketed PALMAZTM and PALMAZ-SCHATZ™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688).
IntraTherapeutics. Inc. device is a balloon expandable stainless steel stent with an open lattice design. The ITI Stent is provided unmounted to be manually crimped onto a noncompliant PTA balloon catheter of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The intended use is "as a palliative treatment for malignant neoplasms in the biliary tree".
Summary of technological characteristics: both products are balloon expandable stents fabricated by cutting an engineered series of slots/apertures into a 316L stainless steel hypotube. The ITI and predicate stent cuts are made with a laser. Both the ITI and predicate stent are cleaned, electro-polished, packaged in a double sterile barrier and sterilized. The ITI stent is ethylene oxide sterilized and the predicate stent CO60. The ITI and predicate stent are provided unmounted, additionally the predicate stent can be provided premounted on a PTA balloon catheter. For the unmounted stent, the predicate offers a separate non-sterile crimping tool while the ITI product does not. Both the TTI stent and predicate stent include use of manual compression using ones thumbs and forefingers to compress the stent onto the delivery balloon catheter.
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K 980290
PL92
IntraTherapeutics, Inc. Premarket Notification
510(k) Summary (Page 2 of 2)
Comparison bench tests regarding performance characteristics were performed on the ITI and predicate stent to demonstrate equivalency. A biocompatibility assessment for cytotoxicity was performed on finished ITI product and determined noncytotoxic. Pyrogenicity testing performed on a lot to lot basis will support the nonpyrogenic claim.
The ITI Stent is substantially equivalent to the currently marketed Cordis Corporation/Johnson & Johnson, legally marketed PALMAZ™ and PALMAZ-SCHATZ™ Balloon-Expandable Biliary Stent as a pailiative treatment for malignant strictures of the biliary tree. As demonstrated the ITI Stent is identical in materials, indication for use and technological characteristics. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the ITI Stent meets the requirements that are considered acceptable for the intended use.
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Image /page/2/Picture/2 description: The image shows a partial view of the Department of Health & Human Services logo. The logo features an abstract depiction of an eagle with three profiles, symbolizing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN" is partially visible, curving around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 1998
Ms. Amy Peterson Vice President, RA & OA Intra Therapeutics, Inc. 651 Campus Drive St. Paul, MN 55112
Re: K980290
ITI Biliary Stent Dated: April 30, 1998 Received: May 1, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE
Dear Ms. Peterson:
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 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). 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, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 (OS) for Medical Devices: General regulation (2) 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in yitty 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/dsmaln.html".
Sincerely yours.
Lillian Yin, Ph.D.
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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K980290 510(k) Number (if know):
Device Name: ITI Stent
Indication For Use:
The ITI Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree. 1
(PLEASE DO NOT WRITE BELOW THIS LINE \CONTIUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tyler Q. Ratliff/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1380290 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.