(71 days)
Not Found
No
The summary describes a physical catheter device and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is described as introducing interventional devices and providing access/reinforcement for other intravascular devices, not directly treating or curing a condition itself.
No
The device is described as an access catheter for introducing interventional devices, not for diagnosing conditions.
No
The device description clearly details a physical catheter with various material components (stainless steel, Nitinol, PTFE), a radiopaque markerband, and accessories (hemostasis valve, tip shaping mandrel). This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neurovasculature." This describes a device used within the body for a therapeutic or interventional procedure, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels to facilitate other procedures. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
The DDC™ Catheters are indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The DDC™ Catheters are variable stiffness catheter with various diameters, a catheter shaft reinforced with a stainless steel or Nitinol coil, and have a radiopaque markerband on the distal end. They are available in various lengths. The DDC™ Catheters have a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The DDC™ Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The devices are provided sterile and include a rotating hemostasis valve and tip shaping mandrel. The DDC™ Catheters will be available in various configurations to allow physician ease of device tracking to the target site
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing found the DDC™ Catheters to be biocompatible and non-pyrogenic. The physical, mechanical and performance testing of the subject DDC™ Catheters demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
| Attribute | Acceptance Criteria | Results |
|---|---|---|
| DDC must be compatible with 6F sheath | 100% Pass | 100% Pass |
| DDC tracking over 0.038" guidewire | 100% Pass | 100% Pass |
| 0.038" Guidewire Compatible | 100% Pass | 100% Pass |
| Hub Transition | 100% Pass | 100% Pass |
| Microcatheter compatibility | 100% Pass | 100% Pass |
| Microcatheter friction | 100% Pass | 100% Pass |
| Microcatheter support | 100% Pass | 100% Pass |
| 0.038in guidewire compatibility | 100% Pass | 100% Pass |
| (Friction Force) (DDC 5MAX only) | 100% Pass | 100% Pass |
| Torsion (DDC 4MAX only) | 100% Pass | 100% Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K093970, K072718, K090752, K113163
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary
Sponsor/Applicant Name and Address 1.1
Penumbra Inc.
1351 Harbor Bay Parkway Alameda, CA 94502
Sponsor Contact Information 1.2
Seth A. Schulman
Director, Regulatory Affairs Phone: 510-748-3223 FAX: 510-217-6414 email: seth.schulman@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
September 7, 2012
Device Trade or Proprietary Name 1.4
DDC™ Catheters
1.5 Device Common/Usual or Classification Name
Catheter, Percutaneous (Product Code: DQY)
NOV 2 0 7012
1
Identification of the Legally Marketed Devices to which Equivalence 1.6 is Being Claimed:
| Name of Predicate Device | Name of Manufacturer
(Town, State) | 510(k) Number |
|------------------------------------------|---------------------------------------|----------------------------------|
| Penumbra PICA™ Catheter | Penumbra, Inc
Alameda, CA | K093970 |
| Penumbra System Reperfusion
Catheters | Penumbra, Inc
Alameda, CA | K072718,
K090752 &
K113163 |
1.7 Device Description:
The DDC™ Catheters are variable stiffness catheter with various diameters, a catheter shaft reinforced with a stainless steel or Nitinol coil, and have a radiopaque markerband on the distal end. They are available in various lengths. The DDC™ Catheters have a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The DDC™ Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The devices are provided sterile and include a rotating hemostasis valve and tip shaping mandrel. The DDC™ Catheters will be available in various configurations to allow physician ease of device tracking to the target site
1.8 Intended Use:
The DDC™ Catheters are indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Comparison to Predicate Devices 1.9
The DDC™ Catheters include design modifications that enable improved trackability and therapeutic device deliverability to the vasculature. This submission also includes larger lumen catheters in various lengths compared to the predicate PICA™ Catheter.
| | | Penumbra System
Reperfusion Catheters | PICA™ Catheter | Subject DDC™
Catheters |
| -- | -- | ------------------------------------------ | ---------------- | --------------------------- |
|---|
1.6
2
| | Penumbra System
Reperfusion Catheters | PICATM Catheter | Subject DDCTM
Catheters |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indication | The Penumbra System™
is intended for use in the
revascularization of
patients with acute
ischemic stroke
secondary to intracranial
large vessel occlusive
disease (within the
internal carotid, middle
cerebral - M1 and M2
segments, basilar, and
vertebral arteries) within
8 hours of symptom
onset. | The PICA™ Catheter
is indicated for the
introduction of
interventional devices
into the peripheral and
neuro vasculature. | SAME
(PICA) |
| Materials | | | |
| - Catheter
Shaft/Hub | Nylon, PTFE,
Polyurethane,
Polycarbonate,
hydrophilic coating | Nylon, PTFE,
Polyurethane,
Polycarbonate,
hydrophilic coating | SAME |
| - Catheter shaft
support | Stainless Steel/Nitinol | Stainless Steel | SAME
(Penumbra System
Reperfusion Catheters) |
| - Catheter
Markerband | Platinum / Iridium | Platinum / Iridium | SAME |
| - Packaging | Tyvek/Mylar pouch,
polyethylene hoop
paper packaging card,
SBS carton | Tyvek/Mylar pouch,
polyethylene hoop
paper packaging card,
SBS carton | SAME |
| Sterilization | EtO | EtO | SAME |
| Shelf-Life | 36 Months | 36 Months | SAME |
1.10 Summary of Non-clinical Data:
Biocompatibility tests conducted for the DDC™ Catheters were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for external communicating devices contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
Non-clinical testing found the DDC™ Catheters to be biocompatible and non-pyrogenic. The physical, mechanical and performance testing of the subject DDC™ Catheters demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.
Table 1: DDC Performance Testing
Attribute Acceptance Criteria Results
3
| Attribute | Acceptance Criteria | Results |
|---|---|---|
| DDC must be | ||
| compatible with 6F | ||
| sheath | 100% Pass | 100% Pass |
| DDC tracking over | ||
| 0.038" guidewire | 100% Pass | 100% Pass |
| 0.038" Guidewire | ||
| Compatible | 100% Pass | 100% Pass |
| Hub Transition | 100% Pass | 100% Pass |
| Microcatheter | ||
| compatibility | 100% Pass | 100% Pass |
| Microcatheter | ||
| friction | 100% Pass | 100% Pass |
| Microcatheter | ||
| support | 100% Pass | 100% Pass |
| 0.038in guidewire | ||
| compatibility | 100% Pass | 100% Pass |
| (Friction Force) | ||
| (DDC 5MAX only) | 100% Pass | 100% Pass |
| Torsion | ||
| (DDC 4MAX only) | 100% Pass | 100% Pass |
:
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2012
Penumbra, Inc. c/o Mr. Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K122772
Trade/Device Name: DDCTM Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 7, 2012 Received: September 10, 2012
Dear Mr. Schulman:
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.
5
Page 2 - Mr. Seth A. Schulman
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Joyce M. Whang
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K122772
Device Name: DDC™ Catheters
Indications For Use:
The DDC™ Catheters are indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Prescription Use _ XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number
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