(174 days)
The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ComboCath™ OTW PTA Dilatation Catheter is an 0.014" (0.36mm) guidewire compatible balloon angioplasty catheter with an effective working length of 150cm. The angioplasty catheter includes a semi-compliant distal Balloon of known diameter and length when inflated to recommended pressures.
The device construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the quidewire and injection of fluids via the catheter's Exit Holes that are positioned proximal to the Balloon.
The proximal Hub includes an Inflation Port used for inflation of the Balloon and a standard Touhy-Borst valve with a side port terminated by a Stopcock that permits injection of fluids.
The catheter includes three radiopaque markers to aid angiographic placement of the device.
This document is a 510(k) summary for the ComboCath™ OTW PTA Dilatation Catheter, seeking to demonstrate substantial equivalence to a predicate device. This type of regulatory submission does not typically involve clinical studies with human participants or a "test set" of patients to evaluate performance against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI/ML device would. Instead, "performance" here refers to functional and material equivalence to a legally marketed predicate device.
Therefore, many of the requested categories are not applicable to this submission. I will address the applicable sections and indicate where information is not relevant to this type of device submission.
1. A table of acceptance criteria and the reported device performance
For this medical device (a balloon catheter), "acceptance criteria" and "performance" are framed in terms of substantial equivalence to a predicate device, focusing on design, materials, and functional characteristics rather than diagnostic accuracy or clinical outcomes from a study with a test set.
| Characteristic | Acceptance Criteria (based on predicate device) | Reported Device Performance (ComboCath™ OTW PTA Dilatation Catheter) |
|---|---|---|
| Intended Use | Similar to predicate (PTA in peripheral vasculature, including specific arteries and AV fistulae) | Matches predicate's intended use statement, with minor wording variations but same scope. |
| Design | Over-the-wire (OTW), two-lumen catheter shaft, thermoplastic polymer balloon, radiopaque marker. | Matches predicate's design. |
| Shaft & Balloon Material | Thermoplastic | Thermoplastic |
| Guidewire Compatibility | 0.014" (0.36 mm) | 0.014" (0.36 mm) |
| Compatible Sheath Size | 4F (predicate) | 5F (slightly different, but within acceptable functional range) |
| Balloon Diameter | 1.5 - 4.0 mm (predicate) | 2.5, 3.0, 3.5, 4.0 mm (subset, but within predicate's range) |
| Balloon Length | 20, 30, 40 mm (predicate) | 40 mm (subset, but within predicate's range) |
| Catheter Working Length | 90, 150 cm (predicate) | 150 cm (subset, but within predicate's range) |
| Biocompatibility | Pass ISO 10993-1 requirements | Passed all required testing per ISO 10993-1 |
| Functional Testing | Device functions for intended use (implied comparison to predicate's expected function) | Functional testing was conducted to support substantial equivalence and demonstrate performance for intended use. (Specific metrics not provided in summary) |
Study Proving Acceptance Criteria:
The study proving the acceptance criteria for this device is a benchtop (functional) and materials comparison study, along with biocompatibility testing. This is not a clinical study with patients or an AI performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a "test set" in the context of clinical data for diagnostic or therapeutic efficacy. Performance was evaluated through bench testing and material comparisons.
- Data Provenance: Not applicable.
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. Ground truth, in the sense of expert consensus on clinical cases, is not relevant to this type of device submission. Performance is validated through engineering bench testing and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is related to engineering specifications, material science standards, and established functional performance requirements for similar medical devices. For example, the ground truth for guidewire compatibility is the standard diameter of a 0.014" guidewire, and the ground truth for biocompatibility is compliance with ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Summa Therapeutics, LLC Richard Rush Regulatory Affairs Consultant 257 Castro Street, #216 Mountain View, California 94041
Re: K150452
Trade/Device Name: ComboCath OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 17, 2015 Received: July 21, 2015
Dear Mr. Rush:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150452
Device Name
Summa Therapeutics ComboCath(TM) OTW PTA Dilatation Catheter
Indications for Use (Describe)
The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
Image /page/3/Picture/3 description: The image contains the logo for Summa Therapeutics. The word "SUMMA" is in a bold, sans-serif font and is colored in blue. Below the word "SUMMA" is the word "THERAPEUTICS" in a smaller, sans-serif font and is colored in gray. The logo is simple and modern.
February 19, 2015
To Whom It May Concern:
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) number:
Date Prepared: February 19, 2015
Applicant Information: Summa Therapeutics, LLC 257 Castro Street, #216 Mountain View, CA 94041
Contact Person: Richard Rush, Regulatory Affairs Consultant Phone Number: (650) 766-9666 Fax Number: (650) 560-6383
Device Information:
| Trade Name: | ComboCath™ OTW PTA Dilatation Catheter |
|---|---|
| Common Name: | Balloon Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | LIT |
{4}------------------------------------------------
Physical Description:
The ComboCath™ OTW PTA Dilatation Catheter is an 0.014" (0.36mm) guidewire compatible balloon angioplasty catheter with an effective working length of 150cm. The angioplasty catheter includes a semi-compliant distal Balloon of known diameter and length when inflated to recommended pressures.
The device construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the quidewire and injection of fluids via the catheter's Exit Holes that are positioned proximal to the Balloon.
The proximal Hub includes an Inflation Port used for inflation of the Balloon and a standard Touhy-Borst valve with a side port terminated by a Stopcock that permits injection of fluids.
The catheter includes three radiopaque markers to aid angiographic placement of the device.
Indications for Use:
The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Device:
Boston Scientific (Coyote™ ES) PTA Balloon Dilatation Catheter (K111295)
The devices share similar intended use, technological characteristics, construction, and materials, as are commonly found in intravascular balloon catheters.
Substantial equivalence:
The ComboCath™ OTW PTA Dilatation Catheter's design, materials, operating principles and intended use are substantially equivalent to predicate device Boston Scientific (Coyote™ ES) PTA Balloon Dilatation Catheter (K111295).
Performance
Functional testing was conducted to support the claim of substantial equivalence and to demonstrate performance of the ComboCath™ OTW PTA Dilatation Catheter for its intended use.
{5}------------------------------------------------
Both devices were evaluated and found similar in design and materials as summarized in Table 4-1 below:
| Characteristic | Summa Therapeutics'ComboCath™ OTW PTA DilatationCatheter | Boston Scientific(Coyote ™ ES) PTA Balloon DilatationCatheter (K111295) |
|---|---|---|
| Intended usestatement | The ComboCath OTW PTA DilatationCatheter is indicated for PercutaneousTransluminal Angioplasty (PTA) in theperipheral vasculature, including iliac,femoral, popliteal, infra-popliteal and renalarteries, and for the treatment ofobstructive lesions of native or syntheticarteriovenous dialysis fistulae. | The Coyote ES OTW PTA BalloonDilatation Catheter is indicated forPercutaneous Transluminal Angioplasty(PTA) in the peripheral vasculature,including iliac, femoral, infrapopliteal,popliteal, renal arteries, and for thetreatment of obstructive lesions of native orsynthetic arteriovenous dialysis fistulae. |
| Design | Over-the-wire (OTW)Two lumen catheter shaft : (1) Lumen forballoon inflation and (1) Lumen forguidewireThermoplastic polymer balloonRadiopaque marker | Over-the-wire (OTW)Two lumen catheter shaft : (1) Lumen forballoon inflation and (1) Lumen forguidewireThermoplastic polymer balloonRadiopaque marker |
| Shaft and BalloonMaterial | Thermoplastic | Thermoplastic |
| GuidewireCompatibility | 0.014" (0.36 mm) | 0.014" (0.36 mm) |
| Compatible SheathSize | 5F | 4F |
| Balloon Diameter | 2.5, 3.0, 3.5, 4.0 mm | 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 mm |
| Balloon Length | 40 mm | 20, 30, 40 mm |
| Catheter WorkingLength | 150 cm | 90, 150 cm |
| Table 4-1: Design and Materials Comparison | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -------------------------------------------- |
Biocompatibility
The ComboCath™ OTW PTA Dilatation Catheter is constructed using commonly used materials in other medical devices. The ComboCath™ OTW PTA Dilatation Catheter passed all testing required to demonstrate biocompatibility per ISO 10993-1, Biological Evaluation of Medical Devices.
Summary:
Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to function for its intended use and be substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).