(187 days)
Removing arterial emboli.
Single Lumen Embolectomy catheter with three 100% silicone balloons. Catheter intended for use in removing arterial emboli. Sizes 2 to 7 French.
This document is a 510(k) summary for the Single Lumen Embolectomy Catheter, submitted by American BioMed, Inc. in 1997. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. It does not typically involve detailed studies proving that the device meets specific numerical "acceptance criteria" in the way one might see for digital health or AI/ML devices today.
Based on the provided text, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as defined in your request (with performance metrics, ground truth, expert opinions, etc.) is not present in this 1997 medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and intended use, rather than presenting a performance study with quantitative acceptance criteria against a defined ground truth.
Therefore, many of the requested details are not applicable or cannot be extracted from this type of regulatory submission from this era.
Here's an attempt to address your request based on the available information, noting where information is not present:
Acceptance Criteria and Device Performance for American BioMed's Single Lumen Embolectomy Catheter (K972572)
This 510(k) summary (K972572) for the Single Lumen Embolectomy Catheter does not present explicit, quantitative acceptance criteria or detailed performance study results in the manner requested (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly considered to be comparable to the predicate devices if the technological characteristics and intended use are similar, and safety is maintained.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria (e.g., "must achieve X% accuracy") are not stated, and no performance study with such metrics is reported, this section cannot be directly filled as requested. The "performance" is inferred from the comparison to predicate devices, focusing on design features and intended use.
| Acceptance Criteria Category | Specific Criteria (Expected) | Reported Device Performance (Achieved) |
|---|---|---|
| Substantial Equivalence | Device is as safe and effective as predicate devices. | Conclusion: The modified American BioMed Single Lumen Embolectomy Catheters are equivalent in safety and efficacy to their predicate device (K881455, K905139, and Baxter Fogarty Arterial Embolectomy Catheter). |
| Material Compatibility | Materials used are safe and suitable for medical use. | Body Material: Silicone Compound. Balloon Material: Silicone Compound. (Implied to be safe as per predicate comparison.) |
| Functional Equivalence | Catheter dimensions and balloon inflation characteristics are comparable to predicate devices. | Catheter French Sizes: 2, 3, 4, 5, 6, and 7 (matches predicates). Catheter Length: 40, 60, 80, 100 cm (matches predicates). Inflated Balloon Diameter: Matches predicates for equivalent French sizes. Max Liquid Volume: Generally matches or is comparable to predicate K881455 & K905139. Differences from Baxter predicate are noted but not presented as affecting substantial equivalence. |
| Intended Use | Same intended use as predicate devices. | Intended Use: "Removing arterial emboli" (Same as predicates). |
| Design Modifications Effect | Modifications (number of balloons) do not negatively impact safety or efficacy, and potentially enhance safety (proximal safety balloon). | Changes from K881455 & K905139: three balloons (two at distal, one at proximal for safety) vs. one at distal. This modification is presented as maintaining or improving safety/efficacy. |
2. Sample Size Used for the Test Set and the Data Provenance
This submission does not describe a clinical "test set" in the context of performance evaluation as it would be understood for, say, an AI/ML algorithm. The comparison is based on the technical specifications and intended use of the device against its named predicate devices. There is no mention of a patient-based test set or data provenance (country, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on a comparison of device specifications and intended use to predicate devices, not on expert consensus or adjudication of results from a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document is for a physical medical device (catheter) and does not involve human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the predicate devices. The new device is deemed "substantially equivalent" if it can be shown to be as safe and effective as these predicates, typically through comparative analysis of design, materials, and intended use. There is no mention of pathology, outcomes data, or expert consensus on a test set for this specific submission.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of device development described in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this information is not provided.
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1972572
JAN 1 3 1998
Section 2
510(k) Summary
Single Lumen Embolectorny Catheter American BioMed, Inc. The Woodlands, Texas 77380
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Section 2 510(k) Premarket Notification Summary
July 1997
Steven Rash President and CEO American BioMed, Inc P. O. Box 8429 The Woodlands, Texas 77387-8429 (281) 367-3895 (281) 367-3212 Fax
| CLASSIFICATION NAME: | Catheter, Embolectomy |
|---|---|
| COMMON/USUAL NAME: | Single Lumen Embolectomy Catheter |
| PROPRIETARY NAME: | Single Lumen Embolectomy Catheter |
| CLASSIFICATION: | 21 CFR Part 870.5150 Catheter, Embolectomy |
| PERFORMANCE STANDARDS: | No Performance Standards for the Catheter,Embolectomy are effective as of this date. |
| PREDICATED DEVICE | Catheter Embolectomy K881455 and K905139,American BioMed, (CathLab Corp.) and BaxterFogarty® Arterial Embolectomy Catheter. |
| DEVICE DESCRIPTION | Single Lumen Embolectomy catheter with three100% silicone balloons. Catheter intended for usein removing arterial emboli. Sizes 2 to 7 French. |
| INDICATIONS | Removing arterial emboli. |
| TECHNOLOGICAL CHARACTERISTICS | This modification of K881455 and K905139,changes the number of balloons, two balloons arelocated at the distal end for embolus removalpurpose, the third balloon is located at the proximalend as a safety balloon to prevent over injection offluid. |
| SUBSTANTIAL EQUIVALENCE | The Single Lumen Embolectomy Catheter isequivalent to K881455, K905139, and Baxter |
Section 2 page 1
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Fogarty Arterial Embolectomy Catheter, same intended use, with change in number of balloons.
| Parameter | AmericanBioMed SingleLumenEmbolectomyCatheter | AmericanBioMed SingleLumenCatheterK881455 &K905139 | Baxter FogartyArterialEmbolectomyCatheterK No. Not Foundin FDA 510(k)Data Base |
|---|---|---|---|
| Body Material | SiliconeCompound | SiliconeCompound | Polyvinylchloride |
| Balloon Material | SiliconeCompound | SiliconeCompound | Latex |
| Balloon to Body Bonding | No. All Silicone.Formed throughdipping process | No. All Silicone.Formed throughdipping process | Yes |
| Number of Balloons | Three. Two atdistal end andone at proximalend. | One. At distalend. | One. At distalend. |
| Catheter French Sizes | 2, 3, 4, 5, 6,and 7 | 2, 3, 4, 5, 6,and 7 | 2, 3, 4, 5, 6, and7 |
| Catheter Length | 40, 60, 80, 100cm. | 40, 60, 80, 100cm. | 40, 60, 80, 100cm. |
| Inflated BalloonDiameter | 2 Fr. - 4 mm3 Fr. - 5 mm4 Fr. - 9 mm5 Fr. - 11 mm6 Fr. - 13 mm7 Fr. - 14 mm | 2 Fr. - 4 mm3 Fr. - 5 mm4 Fr. - 9 mm5 Fr. - 11 mm6 Fr. - 13 mm7 Fr. - 14 mm | 2 Fr. - 4 mm3 Fr. - 5 mm4 Fr. - 9 mm5 Fr. - 11 mm6 Fr. - 13 mm7 Fr. - 14 mm |
| Maximum Liquid Volume | 2 Fr. - 0.05 ml3 Fr. - 0.10 ml4 Fr. - 0.50 ml5 Fr. - 0.75 ml6 Fr. - 1.25 ml7 Fr. - 2.00 ml | 2 Fr. - 0.05 ml3 Fr. - 0.10 ml4 Fr. - 0.50 ml5 Fr. - 0.75 ml6 Fr. - 1.25 ml7 Fr. - 2.00 ml | 2 Fr. - N/A3 Fr. - 0.20 ml4 Fr. - 0.75 ml5 Fr. - 1.50 ml6 Fr. - 2.00 ml7 Fr. - 2.50 ml |
| Intended Use | Removingarterial emboli | Removingarterial emboli | Removingarterial emboli |
Statement of Similarities and Differences
CONCLUSIONS
The conclusion drawn from the above is that the modified American BioMed Single lumen Embolectomy Catheters are equivalent in safety and efficacy to their predicate device.
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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1998
American Biomed, Inc c/o J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071
Re: K972572 Single Lumen Embolectomy Catheter Requlatory Class: II (two) Product Code: DXE Dated: October 17, 1997 Received: October 21, 1997
Dear Mr. Knauss:
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 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 Reqister. 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.
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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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known)
Device Name: Single Lumen Embolectomy Catheter
Indications for use: Removing arterial emboli.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
1
OR
Over-The-Counter Use
.
R-h
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972572
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).