(194 days)
No
The summary describes a mechanical deflectable sheath for catheter introduction and positioning, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a sheath used for catheter introduction and positioning, which are supportive functions for a medical procedure rather than a direct therapeutic action on the patient.
No
The device is a deflectable sheath used for catheter introduction and positioning, not for diagnosing medical conditions.
No
The device description clearly describes a physical, sterile, disposable sheath with a handle, rotating knob, and deflectable distal section, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous catheter introduction into the vasculature and into the chambers of the heart." This describes a device used in vivo (within the body) for accessing and navigating the circulatory system and heart.
- Device Description: The description details a physical device used to guide catheters within the body. It focuses on mechanical features like deflection and torquing for positioning.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is used to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
The CardioFocus Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
Product codes (comma separated list FDA assigned to the subject device)
DRA, DYB
Device Description
The HeartLight® Deflectable Sheath is a sterile, disposable device which provides a conduit for catheter introduction into the vasculature and into the chambers of the heart. The Deflectable Sheath is able to move its distal section in one direction in a single plane and is activated by a rotating knob at the front of the device handle. The deflection of the sheath and the torquing of the device allow the distal end of the sheath to be positioned at the ostium of pulmonary veins.
The Deflectable Sheath is comprised of the following basic elements and features:
- A radio-opaque flexible shaft, 12F ID and 16F OD, having a distal section which is deflectable by means of a wire connected to a mechanism in the handle. The shaft is hollow, comprised of a central lumen through which a catheter or a dilator is able to pass.
- A handle providing a means to torque, deflect and axially position the sheath. Deflection is accomplished by twisting a knob at the distal end of the handle.
- A hemostasis valve located at the proximal end of the central lumen and the handle forms a seal with an inserted object such as a catheter or a guidewire.
- A side port and stopcock connected to the hemostasis valve to permit evacuation of air inside the sheath and to permit constant irrigation of the sheath during use.
- Vent holes located within the soft distal tip allow purging of the sheath when the end of the sheath is pressed against tissue.
- A dilator that is matched to the sheath to provide a smooth transition from a guide wire to the outside diameter of the distal tip of the sheath. The dilator's hub has a lock feature to allow the dilator to be axially locked in relation to the sheath's handle when desired.
- A radio-opaque marker at the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, chambers of the heart, pulmonary veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This device is intended to be used within a hospital or medical facility only by physicians trained in standard transseptal techniques and familiar with angiography and electrophysiology catheters and delivery systems.
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)
Design Verification testing was performed for the HeartLight 12F Deflectable Sheath to verify that design outputs meet relevant performance and functional requirements and conforms to the intended use of the device.
Performance and functional requirements testing included:
12F Sheath and dilator size:
Sheath overall and free length, Sheath tube O.D., tip I.D., tip wall thickness, marker band location, Sheath side port diameter and location, Dilator free length.
12F Sheath functionality
Deflectable sheath testing for accessibility, radiopaque for visibility, ergonomic handle and braided shaft for functionality, hemostasis valve and soft tip for safety. The specific testing included:
- Sheath hemostasis and air leak resistance
- Sheath distal articulation stability, tip articulation max and min, bend radius, kink resistance
- Sheath functionality after foreseeable worst case use: constrained geometry, life cycle test, multiple insertions and retractions
- Sheath deflection and deflection stability
- Sheath handle actuation: torque required to articulate tip, functionality after handle overtorque
- Sheath injection pressure
- Sheath delamination of PTFE liner
- Catheter rotation test
- Packaging integrity
- Sheath side port joint integrity, Stopcock tubing kink specification
Shelf life testing
The 2 year accelerated shelf life design verification testing was performed to support 2 year shelf life of the 12F Deflectable Sheath. The test results passed the design verification and established a two year shelf life for the HeartLight® 12F Deflectable Sheath.
Sterilization Validation (Ethylene Oxide)
Biocompatibility Testing (Verification)
Biocompatibility tests for the 12F Deflectable sheath and the 12 Dilator were performed according to ISO 10993-1 for an external communicating device in contact with circulating blood for less than 24 hours. The tests were leveraged from the reference device HeartSpan® Steerable Introducer Kit (K132164). The results conclude that the Sheath material passed the required ISO 10993 biocompatibility tests and thus support the use of the materials according to their indications for use.
The device were subjected to the following tests:
C3a Complement Activation Assay SC5b-9 Complement Activation Assay ASTM Partial Thromboplastin Time USP Pyrogen Study – Material Mediated ISO Systemic Toxicity Study in Mice ISO Intracutaneous Study in Rabbits ASTM Hemolysis Study
Cytotoxicity Study Using the ISO Elution Method ISO Guinea Pig Maximization Sensitization Test Thromboresistance Study in the Sheep, Heparinized Model
The testing demonstrates that the device does not raise questions of safety or effectiveness when compared to the predicate. The Design Verification testing demonstrated that design outputs met relevant performance and functional requirements and conforms to the intended use/indications of use for the device.
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.
FlexCath® Advance™ Steerable Sheath & Dilator, Model 4FC12 (K123591)
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.
HeartSpan® Steerable Introducer, Models FST-085-00 FST-085-01 and FST-085-02 (K132164)
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
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that suggests a sense of community and support. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2016
Cardiofocus, Inc. Seema Paliwal Regulatory Affairs Specialist II 500 Nickerson Road Suite 500-200 Marlborough, Massachusetts 01752
Re: K152310
Trade/Device Name: HeartLight Deflectable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA, DYB Dated: February 17, 2016 Received: February 18, 2016
Dear Seema Paliwal:
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 device
1
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 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 vours.
Mitchell Stein
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
510(k) Number (if known) K152310
Device Name HeartLight® Deflectable Sheath
Indications for Use (Describe)
The CardioFocus Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
| Type of Use (Select one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for CardioFocus. The logo consists of the word "CardioFocus" in a stylized font, with a curved line extending from the top of the "C" in "Cardio" to the top of a red heart shape to the right of the word "Focus". The font is black, and the heart is red with a white highlight.
| 5.0 | 510(k) Summary - K152310 |
|---|---|
| 5.1 | General Information: |
| Date Summary Prepared: | February 17, 2016 |
| Applicant: | CardioFocus Inc. |
| 500 Nickerson Road | |
| Marlborough, MA 01752 | |
| Telephone: (508) 658-7200 | |
| Fax: (508) 480-0600 | |
| Establishment Registration No.: | 1225698 |
| Contact Person: | Seema Paliwal, PhD, RAC |
| Regulatory Affairs Specialist II | |
| Telephone (direct dial): (508) 658-7208 | |
| Fax: (508) 480-0600 | |
| Email: spaliwal@cardiofocus.com | |
| Trade Name: | HeartLight® Deflectable Sheath |
| Common Name: | Steerable Sheath and Dilator |
| Classification Name: | Steerable Catheter |
| Classification & Panel: | Class II, 21 CFR § 870.1280, Cardiovascular |
| Product Code: | DRA, DYB |
| Predicate Device(s): | FlexCath® Advance™ Steerable Sheath & Dilator, Model 4FC12 (K123591) |
| Reference Device(s): | HeartSpan® Steerable Introducer, Models FST-085-00 FST-085-01 and FST-085-02 (K132164) |
5.2 Device Description
The HeartLight® Deflectable Sheath is a sterile, disposable device which provides a conduit for catheter introduction into the vasculature and into the chambers of the heart. The Deflectable Sheath is able to move its distal section in one direction in a single plane and is activated by a rotating knob at the front of the device handle. The deflection of the sheath and the torquing of the device allow the distal end of the sheath to be positioned at the ostium of pulmonary veins.
4
Image /page/4/Picture/0 description: The image shows the logo for CardioFocus. The logo consists of the word "CardioFocus" in a black, sans-serif font. Above the text is a black curved line that starts above the "C" in "CardioFocus" and ends at a red heart shape to the right of the text. The heart has a white spot on it, giving it a three-dimensional appearance.
The Deflectable Sheath is comprised of the following basic elements and features:
- A radio-opaque flexible shaft, 12F ID and 16F OD, having a distal section which is deflectable by means of a wire connected to a mechanism in the handle. The shaft is hollow, comprised of a central lumen through which a catheter or a dilator is able to pass.
- A handle providing a means to torque, deflect and axially position the sheath. Deflection is accomplished by twisting a knob at the distal end of the handle.
- A hemostasis valve located at the proximal end of the central lumen and the handle forms a seal with an inserted object such as a catheter or a guidewire.
- . A side port and stopcock connected to the hemostasis valve to permit evacuation of air inside the sheath and to permit constant irrigation of the sheath during use.
- Vent holes located within the soft distal tip allow purging of the sheath when the end of the sheath is pressed against tissue.
- A dilator that is matched to the sheath to provide a smooth transition from a guide wire to the outside diameter of the distal tip of the sheath. The dilator's hub has a lock feature to allow the dilator to be axially locked in relation to the sheath's handle when desired.
- A radio-opaque marker at the distal tip.
This device is intended to be used within a hospital or medical facility only by physicians trained in standard transseptal techniques and familiar with angiography and electrophysiology catheters and delivery systems.
5.3 Intended Use
Facilitates introducing various cardiovascular catheters into the heart.
5.4 Indications for Use
The HeartLight" Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
The new device has identical indications for use as the predicate device, FlexCath® Advance™ Steerable Sheath. Both, the new device and the predicate device are intended for introducing and positioning catheters to reach the superior and inferior pulmonary veins of the heart and thus have clinically equivalent therapeutic use.
The reference device, HeartSpan® Steerable Introducer from Merit Medical is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum. The CardioFocus sheath has similar indications for use as the reference device.
5.4.1 Comparison to the Predicate Device
The CardioFocus Deflectable Sheath is compared to the currently marketed predicate device FlexCath Advance™ Steerable Sheath (K123591) in the following table:
5
Image /page/5/Picture/0 description: The image shows the word "CardioFocus" in black font. A black curved line extends from above the "C" in CardioFocus to a red heart shape to the right of the word. The heart is slightly blurred, giving it a soft, glowing appearance.
| Element of Comparison | FlexCath® Advance™ Steerable | HeartLight® Deflectable Sheath |
|---|---|---|
| Sheath (K123591) | (K152310) | |
| (Predicate device) | (New Device) | |
| Intended Use/ Indications for Use | ||
| Intended Use | Facilitates introducing various | Facilitates introducing various |
| cardiovascular catheters into the | cardiovascular catheters into the | |
| Indications for Use | heart. | |
| The FlexCath Advance Steerable | heart. | |
| The CardioFocus Deflectable | ||
| Sheath is intended | ||
| for | Sheath is indicated | |
| for | ||
| percutaneous | ||
| catheter | percutaneous | |
| catheter | ||
| introduction | ||
| into | ||
| the | into | |
| introduction | ||
| the | ||
| vasculature and into | ||
| the | and into | |
| vasculature | ||
| the | ||
| chambers of the heart. The | chambers of the heart. The | |
| sheath deflection facilitates | sheath deflection facilitates | |
| catheter positioning. | catheter positioning. | |
| Sterility, Shelf Life | ||
| Usage | Single use and disposable | Same |
| Sterilization Method | Sterilized with ethylene oxide. | Same |
| Shelf Life | 2 years | Same |
| Storage Conditions | Store in a cool, dark, dry place. | Same |
| Performance/ Technology/Design | ||
| Steerable | ||
| sheath | ||
| improves | ||
| to | ||
| access | ||
| hard-to-reach | ||
| anatomy | Yes | Same |
| Radiopaque for visualization | ||
| under fluoroscopy - Radiopaque | ||
| tip marker for enhanced fluoro | ||
| visibility | Yes | Same |
| Uni-directional curve deflection | ||
| Hemostasis valve to prevent | ||
| blood leakage and or air ingress | Yes ≥ 135° | |
| Yes | Similar ≥ 130° | |
| The deflection angle provides | ||
| maneuverability to the catheters | ||
| that advance through the sheath | ||
| for access to the chambers of | ||
| the heart. The difference in | ||
| deflection angle is minimal and | ||
| does not affect the safety and | ||
| effectiveness of the new device | ||
| relative to the predicate device. | ||
| Bench testing of the sheath | ||
| supports the device design. | ||
| Same | ||
| Ergonomic handle to provide | Yes | Same |
| comfort | ||
| Element of Comparison | FlexCath® Advance™ Steerable | |
| Sheath (K123591) | ||
| (Predicate device) | HeartLight® Deflectable Sheath | |
| (K152310) | ||
| (New Device) | ||
| Soft, atraumatic tip to minimize | ||
| the likelihood of perforation or | ||
| damage to atrial or venous | ||
| tissue. | Yes | Same |
| Braided shaft provides | ||
| exceptional torquability, | ||
| pushability, and kink resistance | Yes | Same |
| Sideport for infusion and | ||
| contrast injection | Yes | Same |
| Usable Length | 65 cm | 75 cm |
| Different from predicate. | ||
| Usable length of the sheath | ||
| provides greater accessibility. | ||
| The shaft usable length should | ||
| be long enough to place 13 cm of | ||
| sheath into the chambers of the | ||
| heart. Bench testing of the | ||
| sheath supports the device | ||
| design. | ||
| Inner Diameter | 12F | 12F - Same |
| Dilator to Guide wire | ||
| Compatibility | Accepts up to 0.035" guidewire | Accepts 0.035" or 0.038" |
| guidewire | ||
| Similar. Dilator to Guide wire | ||
| compatibility defines the | ||
| specification of guide wire | ||
| accepted by the device. Bench | ||
| testing of the sheath supports | ||
| the device design. | ||
| Biocompatibility - The device | ||
| may contact circulating blood or | ||
| have indirect blood contact for | ||
| up to 24 hours | Yes | Same nature and duration of |
| bodily contact. | ||
| Materials | ||
| Shaft Material | Pebax with Barium Sulfate, | |
| stainless steel braid and PTFE | ||
| liner | Same. Stainless Steel Braid | |
| Reinforced Pebax with Barium | ||
| Sulfate with Stainless Steel Pull- | ||
| Wire, PTFE Lined | ||
| Hemostasis valve material | Silicone | Same |
| Hemostasis hub and cap | ||
| material | Polycarbonate | Isoplast |
| Element of Comparison | FlexCath® Advance™ Steerable | |
| Sheath (K123591) | ||
| (Predicate device) | HeartLight® Deflectable Sheath | |
| (K152310) | ||
| (New Device) | ||
| Hemostasis valve | Polycarbonate | Same |
| Adhesive (shaft to hub-sheath | ||
| valve assembly) | Cyanoacrylate | Same |
| Dilator shaft and hub material | Polyethylene | Polyethylene with BaSO4 |
| Similar. Biocompatibility testing | ||
| of the sheath supports the | ||
| device materials. | ||
| Pouch material | Tyvek/nylon polyethylene pouch | Same |
6
Image /page/6/Picture/0 description: The image shows the word "CardioFocus" in a stylized font. A black curved line extends from the top of the "C" in "Cardio" to a red heart shape that is positioned to the right of the word "Focus". The heart shape is slightly blurred, giving it a soft appearance.
7
Image /page/7/Picture/0 description: The image shows the logo for CardioFocus. The logo consists of the word "CardioFocus" in a sans-serif font, with a black curved line extending from the top of the "C" in "Cardio" to a red heart shape to the right of the word "Focus". The heart shape has a white highlight on the upper left side.
5.4.2 Technological Characteristics - Comparison of New Device to Predicate Device
The HeartLight Deflectable Sheath has the following similarities to the predicate device FlexCath Advance Steerable Sheath (K123591):
- Identical Intended Use/ Indications for Use
- . Equivalent technological characteristics and basic sheath design - steerable and deflectable sheath for accessibility, radiopaque for visibility, ergonomic handle and braided shaft for functionality, hemostasis valve and soft tip for safety.
- Similar materials
- Same sterilization process and Shelf Life
The new device has minor differences from the predicate in the deflection angle, usable length, dilator to guide wire compatibility and material used on the dilator shaft and hub and hemostasis hub and cap.
The design verification and biocompatibility testing of the HeartLight Deflectable Sheath support the design, performance and use of the materials for their indications for use. The safety and effectiveness of the new device is not compromised relative to the predicate device.
5.5 Summary of Performance Data
Design Verification testing were performed for the HeartLight 12F Deflectable Sheath to verify that design outputs meet relevant performance and functional requirements and conforms to the intended use of the device.
Performance and functional requirements testing included:
8
Image /page/8/Picture/0 description: The image shows the logo for CardioFocus. The logo consists of the word "CardioFocus" in a stylized font, with a black curved line extending from the top of the "C" in "Cardio" to a red heart shape to the right of the word "Focus". The heart shape is slightly blurred, giving it a soft, glowing appearance.
12F Sheath and dilator size:
Sheath overall and free length, Sheath tube O.D., tip I.D., tip wall thickness, marker band location, Sheath side port diameter and location, Dilator free length.
12F Sheath functionality
Deflectable sheath testing for accessibility, radiopaque for visibility, ergonomic handle and braided shaft for functionality, hemostasis valve and soft tip for safety. The specific testing included:
- Sheath hemostasis and air leak resistance
- -Sheath distal articulation stability, tip articulation max and min, bend radius, kink resistance
- -Sheath functionality after foreseeable worst case use: constrained geometry, life cycle test, multiple insertions and retractions
- -Sheath deflection and deflection stability
- -Sheath handle actuation: torque required to articulate tip, functionality after handle overtorque
- -Sheath injection pressure
- -Sheath delamination of PTFE liner
- -Catheter rotation test
- -Packaging integrity
- -Sheath side port joint integrity, Stopcock tubing kink specification
Shelf life testing
The 2 year accelerated shelf life design verification testing was performed to support 2 year shelf life of the 12F Deflectable Sheath. The test results passed the design verification and established a two year shelf life for the HeartLight® 12F Deflectable Sheath.
Sterilization Validation (Ethylene Oxide)
Biocompatibility Testing (Verification)
Biocompatibility tests for the 12F Deflectable sheath and the 12 Dilator were performed according to ISO 10993-1 for an external communicating device in contact with circulating blood for less than 24 hours. The tests were leveraged from the reference device HeartSpan® Steerable Introducer Kit (K132164). The results conclude that the Sheath material passed the required ISO 10993 biocompatibility tests and thus support the use of the materials according to their indications for use.
The device were subjected to the following tests:
C3a Complement Activation Assay SC5b-9 Complement Activation Assay ASTM Partial Thromboplastin Time USP Pyrogen Study – Material Mediated ISO Systemic Toxicity Study in Mice ISO Intracutaneous Study in Rabbits ASTM Hemolysis Study
9
Image /page/9/Picture/0 description: The image shows the word "CardioFocus" in a stylized font. A curved line extends from above the "C" in "Cardio" to the right side of the word, ending at a red heart shape. The heart is positioned to the right of the word "Focus", visually connecting the text and the heart symbol.
Cytotoxicity Study Using the ISO Elution Method ISO Guinea Pig Maximization Sensitization Test Thromboresistance Study in the Sheep, Heparinized Model
The device specification requirements for functionality, performance specifications, physical characteristics, safety characteristics, labeling, packaging and shipping, shelf life, and sterilization all passed the specific tests and engineering evaluations. The testing demonstrates that the device does not raise questions of safety or effectiveness when compared to the predicate.
5.6 Conclusion
CardioFocus, Inc. considers its HeartLight Deflectable Sheath to be substantially equivalent to the currently marketed predicate device FlexCath (K123591). This assessment is based upon analysis of identical indications for use and similar technological characteristics, design, performance and materials used.
Bench testing was performed to support substantial equivalence between the proposed device, HeartLight® 12F Deflectable Sheath and the predicate FlexCath® Advance™ Steerable Sheath (K123591). The Design Verification testing demonstrated that design outputs met relevant performance and functional requirements and conforms to the intended use/indications of use for the device. The 12F Deflectable Sheath has identical intended use/ indications for use and performance specifications to that of the FlexCath® Advance™ Steerable Sheath cleared under K123591. Therefore the bench testing performed demonstrates substantial equivalence with the testing and intended use of primary predicate. The biocompatibility testing does not raise questions of safety or effectiveness since the material used for the 12F Deflectable sheath is the same as the reference device cleared under K132164 and has been in the market for a similar indications for use.
Design verification and biocompatibility testing results indicate that the properties and performance of the device are suitable for its intended use and no new issues of safety or effectiveness have been raised.