(142 days)
The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
The Asahi Angiographic Catheter consists, as its basic structure, of a tube to be inserted into vascular, a proximal hub, and strain relief for the joint section of the first 2 parts. The tube is reinforced by stainless steel braid. The distal tip of the catheter is made soft and has variety configuration in order to easily bend in accordance with the vessel curve. The tube is radiopaque in whole length so as to be easily confirmed its position under radioscopy.
The provided text describes a 510(k) premarket notification for the Asahi Angiographic Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the manner one would see for novel AI software.
Therefore, the following information is extracted and presented as per the request, but many fields will be marked as "Not Applicable" or "Not Provided" due to the nature of this submission being for a physical medical device demonstrating equivalence, not an AI/software device with specific performance metrics.
Acceptance Criteria and Study Details for Asahi Angiographic Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility: Compliance with ISO-10993 series | "The contact materials used to fabricate the Asahi Angiographic Catheters pass the testing required by ISO-10993 series." These materials are "currently used in many disposable medical devices." |
| Bench Testing: Performance similar to predicate devices for relevant characteristics (e.g., tube structure, radiopacity, distal tip flexibility, diameter, length) | "[Bench testing was conducted] to demonstrate that the Asahi Angiographic Catheter met the acceptance criteria and performed similarly to the predicate devices." "The Asahi Angiographic Catheters are made of the same materials, available in the same diameters and lengths, have the same design and indications for use as the predicate devices and other currently marketed angiographic catheters." |
| Intended Use: Delivery of radiopaque contrast medium to selected sites in the vascular system. | "The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system." (Demonstrated to be the same as predicate devices). |
Note: The submission focuses on demonstrating substantial equivalence to predicate devices (K960975, K970854, K862006) by showing that the new device has the same technological characteristics, materials, and intended use. Specific quantitative acceptance criteria (e.g., "burst pressure > X psi" or "flow rate > Y mL/s") are not explicitly stated in this summary, but rather implied by "met the acceptance criteria and performed similarly to the predicate devices."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not provided. The submission refers to "bench and biocompatibility testing" without specifying the number of units tested.
- Data Provenance: Not provided. The testing was conducted by Asahi Intecc Co., Ltd. (Japan) but further details on the location or nature of the test subjects (if applicable beyond bench testing) are not given. It is implied to be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a physical device like an angiographic catheter, ground truth is typically established through engineering specifications, material standards, and functional bench testing, not expert interpretation of outputs.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Performance is evaluated against engineering standards and comparison to predicate devices, not through expert adjudication of results that would typically apply to interpretative diagnostic devices.
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
- MRMC Study: Not applicable. This is a physical medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: Engineering specifications, material standards (ISO-10993 series for biocompatibility), and performance benchmarks established by legally marketed predicate devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI software that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. No training set was used.
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KOS/561
Traditional 510(k)
The Asahi Angiographic Catheter
Asahi Intecc Co., Ltd. June, 2005
NOV - 2 2005
510(k) Summary of Safety and Effectiveness
| Date Prepared: | June, 2005 |
|---|---|
| Submitted: | Asahi Intecc Co., Ltd. |
| 1703 Wakita-cho, Moriyama-ku, Nagoya, | |
| Aichi, 463-0024, Japan. | |
| Contact Person: | Yoshi Terai |
| Director of Asahi Intecc USA Inc. | |
| Address: | 1301 Dove Street, |
| Suite #350 Newport Beach, | |
| CA, 92660, USA | |
| Phone Number: | Phone: (949) 756-8252 |
| Fax Number: | Fax: (949) 756-8165 |
| Device Trade Name: | Asahi Angiographic Catheter |
| Classification Name: | Diagnostic intravascular catheter (per 21 CFR 870.1200) |
| Classification: | Class II |
| Predicate Device: | K960975: 4F Infiniti Angiographic Catheter |
| K970854: 5F and 6F Infiniti Angiographic Catheter | |
| K862006: Stand & High Flow Femoral- Ventricular Pigtail Catheter |
Device Description:
The Asahi Angiographic Catheter consists, as its basic structure, of a tube to be inserted into vascular, a proximal hub, and strain relief for the joint section of the first 2 parts. The tube is reinforced by stainless steel braid. The distal tip of the catheter is made soft and has variety configuration in order to easily bend in accordance with the vessel curve. The tube is radiopaque in whole length so as to be easily confirmed its position under radioscopy.
Intended Use:
The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Device Technological Characteristics and Comparison to Predicate Device:
The Asahi Angiographic Catheters are made of the same materials, available in the same diameters and lengths, have the same design and indications for use as the predicate devices and other currently marketed angiographic catheters.
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Asahi Intecc Co., Ltd. June, 2005
Performance Data:
Bench and biocompatibility testing were conducted according to the relevant ISO to Demonstrate that the Asahi Angiographic Catheter met the acceptance criteria and performed similarly to the predicate devices.
performed summary to the ontact materials used to fabricate the Asahi Angiographic Catheters pass the testing required by ISO-10993 series. These materials are currently used in many disposable medical devices.
Conclusion:
The Asahi Angiographic Catheters are substantially equivalent to the claimed predicates devices and other currently marketed angiographic catheters.
K05156 Premarket Notification [510(k)] Number
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle's head with three stripes extending from the back of the head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the seal.
NOV - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Intec Co., Ltd. c/o Mr. Yoghi Terai Director 1301 Dove Street, #350 Newport Beach, CA 92660
K021561 Asahi Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: September 27, 2006 Received: September 27, 2005
Dear Mr. Terai:
Re:
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 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.
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Page 2 - Mr. Tamas Borsal
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 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), please contact the Office of Compliance at (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duvur R. Wilmer
- Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Asahi Intecc Co., Ltd. September, 2005
Asahi Angiographic Catheter Traditional 510(k)
Indications for Use
510(k) Number (if known): K051561
Device Name: Asahi Angiographic Catheter
Indications For Use:
The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and the same of the same of the same of the same of the seat of the states of the states of the states of the states of the states of the states of the states of the states o
Dmna R. Vichnes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko5156 |
Page 1 of 1
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).