(406 days)
The CAOW Hemostasis System can be used to provide hemostasis for femoral arterial and venous punctures associated with an angiogram, angioplasty, coronary stent placement or other invasive cardiac or radiological procedures.
The CAOW Hemostasis System consists of a pole-mounted C-clamp with movable upper and lower arms. A single-use, sterile acrylic plastic pad attached to the upper arm provides hemostasis by controlled compression of the arterial puncture site.
Here's an analysis of the acceptance criteria and study information for the CAOW Hemostasis System, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device submitted to the FDA in 1998. It is a regulatory document, not a scientific publication detailing a clinical trial with specific methodologies for determining device performance statistically. Therefore, much of the requested information (like specific acceptance criteria values, extensive detail on study design for performance, MRMC studies, or detailed ground truth establishment for training sets) is not present in this type of summary. The summary focuses on demonstrating substantial equivalence to predicate devices, which often involves comparing safety and effectiveness, but not necessarily defining and proving performance against pre-specified numerical acceptance criteria in the same way a modern clinical trial report would.
The document states that a "clinical study demonstrated the safety and proper performance of the CAOW Hemostasis System." However, it does not provide the specific details of this study, nor does it list numerical acceptance criteria with corresponding performance metrics from that study in the way typically requested.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not explicitly state numerical acceptance criteria for its performance or success in terms of hemostasis, nor does it report specific quantified performance metrics from a clinical study within the provided text. The statement is broad: "a clinical study demonstrated the safety and proper performance of the CAOW Hemostasis System."
Therefore, a table cannot be accurately constructed with specific numerical values for acceptance criteria and reported performance based solely on the provided text. The "acceptance" is implied by the FDA's
510(k) clearance, which means the device was found to be "substantially equivalent" to legally marketed predicate devices in terms of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document only states "a clinical study."
- Data Provenance: Not specified. It's unclear if the study was conducted in Canada (where the applicant is located) or elsewhere. The document doesn't mention if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Role in Ground Truth: The document does not describe how "ground truth" was established for a clinical performance study. For a hemostasis device, ground truth would typically relate to successful cessation of bleeding, complication rates, time to hemostasis, etc., which would be assessed by clinical staff involved in the procedure and patient care. Details on the methodology for this assessment are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The summary does not provide details on the study's design or how outcomes were assessed or adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, this type of study is not applicable. MRMC studies are typically used for diagnostic or screening devices where multiple human readers interpret images or data, and their performance with and without an AI algorithm is compared. The CAOW Hemostasis System is a mechanical therapeutic device, not a diagnostic imaging system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, this is not applicable. The CAOW Hemostasis System is a mechanical device that requires human application and monitoring. It does not have an "algorithm" in the sense of AI or software that operates independently.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated or detailed. For a hemostasis device, "ground truth" would generally refer to observed clinical outcomes such as:
- Successful achievement of hemostasis (defined by absence of bleeding or oozing).
- Time to hemostasis.
- Absence of complications (e.g., hematoma formation, pseudoaneurysm, nerve damage, infection related to the device application).
These would be assessed by medical professionals. The specific methodologies for defining and collecting these outcomes as "ground truth" are not provided.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The CAOW Hemostasis System is a mechanical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The clinical study mentioned would be for validation of the device's performance, not for "training" an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for a mechanical device.
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Attachment F
510(k) Summary Compression Apparatus On Wheels (CAOW™) Hemostasis System
General Information
| Device Generic Name: | Arterial puncture mechanicalhemostasis system |
|---|---|
| Device Trade Name: | CAOW Hemostasis System |
| Applicant's Name and Address: | Anlam Corporation10151 74th StreetEdmonton, Alberta T6A 2X8Canada |
| 510(k) Number: | Compressar® (K925809; Instromedix)ClampEase (K863427; Freud MedicalProducts)Disco Pad and Quicklamp (K923085;TZ Medical) |
| Date of Judgement of SubstantialEquivalence Sent to Applicant: | Compressar® (K925809) - 1992ClampEase (K863427) - 1986Disco Pad and Quicklamp (K923085) -1992 |
Description of Conditions for Which the Product is Indicated II.
The CAOW Hemostasis System can be used to provide hemostasis for femoral arterial and venous punctures associated with an angiogram, angioplasty, coronary stent placement or other invasive cardiac or radiological procedures.
Device Description III.
The CAOW Hemostasis System consists of a pole-mounted C-clamp with movable upper and lower arms. A single-use, sterile acrylic plastic pad attached to the upper arm provides hemostasis by controlled compression of the arterial puncture site.
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Alternatives IV.
Alternatives for the CAOW Hemostasis System are other commercially available hemostasis products, such as compression bandages, sutures, mechanical C-clamp pad compression systems, collagen plugs, etc.
: Marketing History V.
The CAOW Hemostasis System is not in commercial distribution in the United States or elsewhere.
Potential Adverse Effects VI.
Potential adverse effects associated with the CAOW Hemostasis System are the same as those associated with other commercially available mechanical C-clamp pad compression systems.
VII. Summarv of Studies
A sterilization validation, mechanical bench testing and a clinical study demonstrated the safety and proper performance of the CAOW Hemostasis System.
VIII. Conclusion
Information presented in this 510(k) Notification demonstrated the substantially equivalency of the CAOW Hemostasis System and provides reasonable assurance that the CAOW Hemostasis System will perform in a safe and effective manner.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1998
Mr. Anthony Lam Anlam Corporation 10536-101 Street T5H 2R8 CANADA
Re: K972689 CAOW Hemostasis System Regulatory Class: II (two) Product Code: 74 DXC Dated: August 11, 1998 Received: August 11, 1998
Dear Mr. Lam:
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 (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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlations.
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Page 2 - Mr. Anthony Lam
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 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
Indications for Use Statement
The indications for use recommended for the Compression Apparatus On Wheels (CAOW™) Hemostasis System are stated in the instruction manual (see Attachment B). This statement is repeated below:
The CAOW Hemostasis System can be used to provide hemostasis for femoral arterial and venous punctures associated with an angiogram, angioplasty, coronary stent placement or other invasive cardiac or radiological procedures.
TAA
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1972689 510(k) Number .
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).