(5 days)
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
The Rex Medical Cleaner™ Rotational Thrombectomy System is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectomy. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
The provided document pertains to a 510(k) premarket notification for the Rex Medical Cleaner™ Rotational Thrombectomy System. This regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria in a detailed study format typically seen for novel devices with extensive performance claims.
Based on the information provided, here's an analysis of the acceptance criteria and the study that indicates the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria that the device had to meet (e.g., "device must remove X% of clot"). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is reported in terms of comparative characteristics and qualitative success in non-clinical and in-vivo testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Rex Medical Cleaner™) |
|---|---|
| Intended Use: Maceration of Clot | Macerates clot into particulate size that is not harmful to the patient. Proven to macerate clot formation in synthetic dialysis grafts. |
| Safety: Device operates without raising new safety questions | In-vivo (animal) test studies proven as safely as the predicate device. Bench testing showed no differences in technological characteristics that raise new safety questions. |
| Effectiveness: Achieve mechanical declotting | In-vivo (animal) test studies proven as effectively and efficiently as the predicate device. |
| Technological Characteristics Comparison | Substantially equivalent in attributes like catheter type, OD, length, drive wire, distal tip, activation, etc. |
| Energy Transmitted to Graft (6mm Id Graft) | 22.6J (Predicate: 31.1J). This difference was deemed not to raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document states that statistical sampling rationale for choosing the number of devices tested was based on ISO 2859-1 sampling plans in accordance with projected lots (batch) size for non-clinical tests. However, the specific number of devices tested for non-clinical performance or the number of animals in the in-vivo study is not provided.
- Data Provenance:
- Non-Clinical/Bench Testing: The geographical origin of this data is not specified. It is likely internal testing conducted by Rex Medical or a contracted lab.
- In-Vivo (Animal) Testing: The document explicitly states "In-Vivo (animal) test studies." The geographical origin is not specified, but it would have been prospective testing.
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)
This type of information is not applicable and not provided for this 510(k) submission. The "ground truth" in this context is established by the physical and functional performance of the device itself (e.g., successful clot maceration, energy output, comparison of physical dimensions) and observed outcomes in animal models, not through expert interpretation of data like in an AI/imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints, which is not the primary focus of the non-clinical and animal studies 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the Rex Medical Cleaner™ is. The device is a mechanical thrombectomy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a mechanical medical device like a thrombectomy system. There is no "algorithm only" performance separate from the physical device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established through:
- Objective measurements and engineering specifications for non-clinical testing (e.g., catheter dimensions, energy output).
- Direct observation of clot maceration and safety outcomes in in-vivo animal studies. This would effectively be a form of direct observation of the physiological effect of the device, akin to outcomes data in a controlled environment.
8. The sample size for the training set
This information is not applicable as there is no "training set" for a mechanical medical device like this, which does not employ machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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MAY 27 2003
Exhibit #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assianed 510(k) number is:
1. Submitter's Identification:
Rex Medical 555 North Lane Suite 6101 Conshohochen, PA 19428
Contact: Mr. Michael Paris
Date Summary Prepared:
April 14, 2003
2. Name of the Device:
Rex Medical Cleaner™ Rotational Thrombectomy System".
3. Predicate Device Information:
-
- K#990829, Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA K#970080, Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA
-
- K#003570, Solera™ Bacchus™ Thrombectomy Catheter (BTC), Bacchus Vascular, Inc. Santa Clara, CA
4. Device Description:
The Rex Medical Cleaner™ Rotational Thrombectomy System is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectomy. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.
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5. Intended Use:
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
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Comparison to Predicate Devices: 6.
| Attribute | Rex Medical Cleaner™ RotationalThrombectomy System (SubjectDevice) | Arrow PTD (Predicate Device) |
|---|---|---|
| Catheter Type | Mechanical Thrombectomy Catheter | Mechanical Thrombectomy Catheter |
| Intended Use | Maceration of Clot | Maceration of Clot |
| Catheter Outer Diameter | 6F Sheath Compatible | 6F Sheath Compatible |
| Catheter Length | 65cm | 65cm |
| Drive Wire Diameter | .035" | 0.041" |
| Cleaning Device Wire | .035" Guidewire | Nitinol Basket (0.015" X 4 Wires) |
| Distal Catheter Tip Configuration | Radiopaque Tip | Radiopaque Tip |
| Distal Wire Tip Configuration | Atraumatic Radiopaque Soft DistalTip | Atraumatic Radiopaque Soft DistalTip |
| Cleaning Device | Sinusoidal Wave formed in DriveWire | Wire Basket Added to End of DriveWire |
| Activation Switch | Push Button Switch Located onHandle | Push Button Switch Located onHandle |
| Means to Protect Distal WireSegment | Slide Mechanism on Handle to SlideCatheter Over Cleaning Device | Slide Mechanism on Handle to SlideCatheter Over Cleaning Device |
| Side-Port Extension | Located on Handle | Locate on Handle |
| w/Female Luer | ||
| Ergonomic Handle | Yes | Yes |
| Packaging | Tray w/Tyvek Lid | Tray w/Tyvek Lid |
| Energy Transmitted to Graft fromDevice (6mm Id Graft) | 22.6J | 31.1J |
.
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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Performance testing, which includes testing protocols, testing results and conclusions, based on ISO 10555-1, and FDA's "Guidance on Pre-market Notification (510(k)) Submission for Short-Term and Long-Term Intravascular Catheters", was submitted with this submission.
Statistical sampling rationale for choosing the number of devices that were tested was based on ISO 2859-1 sampling plans in accordance with our projected lots (batch) size.
Testing results revealed that the Rex Medical Cleaner™ Rotational Thrombectomy System device is substantially equivalent to the predicate device.
8. Discussion of Clinical Tests Performed:
In-Vivo (animal) test studies have proven that the Cleaner™ Rotational Thrombectomy device will macerate clot formation in synthetic dialysis grafts as effectively, efficiently, and as safely as the predicate device.
ல் Conclusions:
The subject device, Rex Medical Cleaner™ Rotational Thrombectomy System. has the same intended use as the predicate devices, the Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, and the Solera™ Bacchus™Thrombectomy Catheter (BTC). Moreover, bench testing contained in our submission and the non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the Rex Medical Cleaner™ Rotational Thrombectomy System is substantially equivalent to the predicate devices.
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MAY 27 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rex Medical, Inc. c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021
Re: K031610
Cleaner™ Rotational Thrombectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II (two) Product Code: MCW Dated: May 21, 2003 Received: May 22, 2003
Dear Ms. Goldstein-Falk:
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. Iisting 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 - Ms. Susan D. Goldstein-Falk
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 (301) 594-4648. 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/dsma/dsmamain.html
Sincerely yours,
Kelleher
uckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
ﻨﺪ ﺗﻢ ﺗﺮ
Page _ 1 of
510(k) Number (if known): K031610
Device Name: Rex Medical Cleaner™ Rotational Thrombectomy System
Indications For Use:
The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031610
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).