(8 days)
The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.
The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths.
The provided text describes a Special 510(k) submission for the Micro Therapeutics, Inc. TruLine™ Reinforced Valved Infusion Catheter (K021139). This submission focuses on establishing substantial equivalence to a predicate device, which usually involves a different type of testing than what would be described for an AI/ML powered device, and therefore does not include detailed information on acceptance criteria and a study design in the way an AI/ML device would.
Based on the information provided, here's what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantifiable acceptance criteria and corresponding performance metrics in the way an AI/ML device submission would. Instead, it states that "All testing yielded acceptable results" for a range of physical and biocompatibility tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Confirmed in accordance with ISO 10993-1 as an external communicating, blood contact, limited exposure (<24 hrs) device. "Acceptable results". |
| Dimensional Inspection | "Acceptable results" |
| Tensile Strength | "Acceptable results" |
| Burst Pressure | "Acceptable results" |
| Flow Rate | "Acceptable results" |
| Cyclic Fatigue | "Acceptable results" |
| Performance under simulated conditions | "Acceptable results" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. It also does not mention data provenance as it pertains to a clinical test set. The testing described is in-vitro performance testing and biocompatibility testing, not clinical trials with human participant data.
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. The ground truth for this type of device (an infusion catheter) is established through standardized engineering and biocompatibility testing, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human interpretation of data, typically in clinical studies, which is not described here.
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 device is not an AI/ML product for interpretation or diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, an infusion catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility testing, the ground truth is established by adherence to ISO 10993-1 standards and the specific endpoints defined within those tests (e.g., cytotoxicity, sensitization, irritation).
For the in-vitro performance testing (dimensional, tensile, burst, flow rate, cyclic fatigue), the "ground truth" is defined by pre-established engineering specifications and performance limits for the device. The device's performance is compared against these engineering standards.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product and does not involve a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided information indicates that the device's acceptable performance and substantial equivalence were established through:
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. This testing confirmed the biocompatibility of the catheter for its intended use as an external communicating, blood contact, limited exposure (<24 hrs) device.
- In-vitro Performance Testing: Included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, cyclic fatigue tests, and performance under simulated conditions. The submission states that "All testing yielded acceptable results," implying that the device met pre-defined engineering specifications and performance criteria for each of these physical and functional characteristics.
The document emphasizes that this testing verified the device's performance and confirmed its substantial equivalence to the predicate device in terms of intended use and principles of operation, rather than detailing a clinical study with quantifiable metrics often found in AI/ML device submissions.
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Micro Therapeutics, Inc.
Special 510(k): TruLine™ Reinforced Valved Infusion Catheter
Attachment 4
| 510(k) Summary | |
|---|---|
| Prepared: | April 5, 2002 |
| TRADE NAME | TruLine ™ |
| GENERIC NAME | Catheter, Intravascular, Therapeutic, Short-Term |
| CLASSIFICATION | Class II (21 CFR 880.5200) |
| SUBMITTED BY | Micro Therapeutics, Inc. |
| 2 Goodyear | |
| Irvine, CA 92618 |
| CONTACT | Tom Daughters |
|---|---|
| Regulatory Affairs | |
| (949) 837-3700 |
| PREDICATE DEVICE | TruLine™ Reinforced Valved Infusion Catheters |
|---|---|
| DEVICE DESCRIPTION | The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths. |
| INDICATIONS FOR USE | The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature. |
| TESTING | Biocompatibility of the MTI TruLine™ Reinforced Valved Infusion Catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the catheter when tested as an external communicating, blood contact, limited exposure (<24 hrs) device. In-vitro performance testing of the MTI TruLine™ Reinforced Infusion Catheter included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, cyclic fatigue tests and performance under simulated conditions. All testing yielded acceptable results. |
| SUMMARY OF SUBSTANTIAL EQUIVALENCE | The MTI TruLine™ Reinforced Infusion Catheter is substantially equivalent to the predicate device in intended use and principles of operation. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Mr. Tom Daughters Director, Regulatory Affairs Micro Therapeutics, Incorporated 2 Goodyear Irvine, California 92618
Re: K021139
Trade/Device Name: TruLine™ Reinforced Valved Infusion Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 5, 2002 Received: April 9, 2002
Dear Mr. Daughters:
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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
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.
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You must comply 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Micro Therapeutics, Inc.
Special 510(k): TruLine™ Reinforced Valved Infusion Catheter
Attachment 2
Indications for Use Statement
510(k) Number (if known): 5021139
Device Name:
TruLine™ Reinforced Valved Infusion Catheter
Indications for Use:
The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of pharmacologic physician-specified agents or radiopaque contrast media general the into vasculature.
Patrica Currente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over the Counter Use_
(Per 21 CFR 801.109)
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).