VasoStat Hemostasis Device

K153259 · Forge Medical, Inc. · DXC · Jan 6, 2016 · Cardiovascular

Device Facts

• Record ID: K153259
• Device Name: VasoStat Hemostasis Device
• Applicant: Forge Medical, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jan 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Device Story

VasoStat™ Hemostasis Device is a vascular compression device used by medical professionals to achieve hemostasis post-catheterization or vascular puncture. The device consists of a flexible thermoplastic base secured to the patient's skin via biocompatible adhesive pads. A plunger component, operated via a one-handed ratcheting mechanism, applies adjustable, targeted pressure to the puncture site. This compression promotes hemostasis while minimizing thrombosis risk. Used in clinical settings, the device is applied directly over the puncture site on the arm or lower leg. Once hemostasis is achieved (typically 15-45 minutes), the device is removed and discarded. The device benefits patients by providing controlled, adjustable pressure to stop bleeding, particularly in patients on anticoagulation therapy.

Clinical Evidence

Retrospective evaluation of 314 patients following transpedal access for peripheral vascular disease intervention. Results demonstrated the device successfully achieved hemostasis with low rates of pseudo-aneurysm and access site occlusion. Benchtop and animal testing from K123041 were leveraged to support the expanded indications.

Technological Characteristics

Flexible thermoplastic base; biocompatible adhesive pads; ratcheting plunger mechanism for adjustable compression. Materials comply with ISO 10993 biocompatibility standards. Standalone, non-powered, single-use device.

Indications for Use

Indicated for patients undergoing catheterization or vascular puncture in the arm or lower leg, including radial, pedal, or tibial artery access, arterial/venous line removal, and hemodialysis. Suitable for patients on anticoagulation therapy.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• VasoStat™ Hemostasis Device (K123041)
• RadAR™ Vascular Compression Assist Devices (K142122)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 06, 2016

Forge Medical, Inc. c/o Mason Diamond, DDS Texel Fortis, LLC 150 Levinberg Lane Wayne, NJ 07470

Re: K153259

Trade/Device Name: VasoStat™ Hemostasis Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: November 7, 2015 Received: November 10, 2015

Dear Dr. Diamond:

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-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.

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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 [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M.A. Hillebrand

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K153259

Device Name VasoStat™ Hemostasis Device

#### Indications for Use (Describe)

The VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

| Submitter Name: | Forge Medical, Inc |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 791 West Broad Street, Suite 102<br>Bethlehem, PA 18018 |
| Phone Number:<br>Fax Number: | 215-605-3225<br>866-244-8988 |
| Contact Person: | Mason Diamond, DDS<br>Texel Fortis, LLC<br>150 Levinberg Lane<br>Wayne, NJ 07470<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | 10 December, 2015 |
| Device Trade Name: | VasoStatTM Hemostasis Device |
| Common Name | Vascular compression device |
| Classification Name<br>Number and<br>Product Code: | Vascular clamp<br>870.4450<br>DXC |
| Predicate Devices: | VasoStatTM Hemostasis Device (Forge Medical): K123041<br>RadARTM Vascular Compression Assist Devices (Advanced<br>Vascular Dynamics): K142122 |
| Device Description | VasoStatTM Hemostasis Device is a device that is adhered to the<br>patient's skin directly over a percutaneous vascular puncture site<br>and allows the application of adjustable compression to the<br>puncture site to achieve hemostasis. The device is composed of<br>a flexible thermoplastic base that has the ability to conform to the<br>patient's anatomy (e.g. lower arm, upper arm, foot) and is secured<br>to the skin with biocompatible adhesive pads. A plunger<br>component passes through the base, applies targeted pressure to<br>the puncture site through a ratcheting mechanism, and can be<br>adjusted with one hand to apply the appropriate pressure<br>necessary to promote hemostasis. VasoStat has the ability to vary<br>the amount of pressure applied to the puncture site to promote<br>hemostasis while minimizing the risk of thrombosis. The device |
| Submitter:<br>Forge Medical, Inc. | VasoStat™ Hemostasis Device<br>Premarket Notification: Traditional 510(k) |
| | design and materials ensure that the product is comfortable for<br>the patient to wear while their puncture site stops bleeding. Once<br>hemostasis is achieved (in approximately 15 to 45 minutes), the<br>device is easily removed and discarded. |
| Statement of<br>Indications for Use | The VasoStat™ Hemostasis Device is indicated for use by<br>medical professionals to promote hemostasis following a<br>catheterization or other puncture into a blood vessel in a patient's<br>arm or lower leg, including radial artery catheterization, pedal or<br>tibial artery catheterization, arterial or venous line removal,<br>hemodialysis, and in patients on anticoagulation therapy. |
| Summary of<br>Technological<br>Characteristics | The VasoStat™ Hemostasis Device is designed to provide local<br>compression to the puncture site into a blood vessel of the arm or<br>lower leg, including arterial sheath placement and dialysis shunt<br>access. The degree of pressure is designed to stop bleeding<br>without causing vessel thrombosis. The VasoStat™ Hemostasis<br>Device is the same as that previously cleared by the FDA<br>(K123041), and functions in the same way. Though different in<br>design, the VasoStat™ Hemostasis Device provides sufficient<br>compression to stop bleeding in pedal arterial catheterizations<br>similar to the RadAR™ Vascular Compression Assist Devices,<br>which also utilize compression to stop bleeding (K142122). |
| Performance<br>Testing | Since this submission applies to the VasoStat™ Hemostasis<br>Device to revise the indications for use without any changes to<br>device design, the benchtop and animal testing reported in<br>K123041 has been leveraged to demonstrate that the submitted<br>device is appropriate for the new indications for use. Similarly,<br>biocompatibility for this device has already been established per<br>ISO-10993 (K123041).<br><br>Furthermore, the VasoStat™ Hemostasis Device was<br>retrospectively evaluated in three-hundred fourteen (314) patients<br>following transpedal access for peripheral vascular disease<br>intervention. The analysis concluded that the VasoStat™<br>Hemostasis Device was capable of achieving hemostasis<br>following transpedal catheterization with low rates of pseudo-<br>aneurysm and access site occlusion. |
| Substantial<br>Equivalence | The VasoStat™ Hemostasis Device is Substantially Equivalent to<br>predicate VasoStat™ Hemostasis Device (K123041), with respect<br>to technical and design features. The Indications for Use and<br>Mode of Action is Substantively Equivalent to the RadAR™<br>Vascular Compression Assist Devices (K142122). |
| Conclusion | The information discussed above demonstrates that the<br>VasoStat™ Hemostasis Device is substantially equivalent to the<br>predicate device. |

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# Summary of Substantial Equivalence

| Feature | VasoStat™ Hemostasis<br>Device | VasoStat™ Hemostasis<br>Device | RadAR™ Vascular<br>Compression Assist<br>Devices |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K153259 | K123041 | K142122 |
| Class | II | II | II |
| Classification | Vascular clamp | Vascular clamp | Vascular clamp |
| Regulation | 870.4450 | 870.4450 | 870.4450 |
| Product Code(s) | DXC | DXC | DXC |
| Indications for<br>Use | ...indicated for use by<br>medical professionals to<br>promote hemostasis<br>following a catheterization<br>or other puncture into a<br>blood vessel in a patient's<br>arm or lower leg, including<br>radial artery<br>catheterization, pedal or<br>tibial artery catheterization,<br>arterial or venous line<br>removal, hemodialysis, and<br>in patients on<br>anticoagulation therapy. | ...indicated for use by<br>medical professionals to<br>promote hemostasis<br>following a catheterization<br>or other puncture into a<br>blood vessel in a patient's<br>arm, including radial artery<br>catheterization, arterial or<br>venous line removal,<br>hemodialysis, and in<br>patients on anticoagulation<br>therapy. | ...indicated for use by<br>medical professionals to<br>promote hemostasis<br>following a catheterization<br>or other puncture into a<br>blood vessel in a patient's<br>arm or leg, including radial<br>brachial, dorsalis, pedis, or<br>tibial blood vessels, arterial<br>or venous line or sheath<br>removal, hemodialysis, and<br>in patients on<br>anticoagulation therapy. |
| Mode of Action | Compression | Compression | Compression |
| Composition | Same a predicate | Molded<br>Polypropylene/Polyethylen<br>e Foam/Acrylic Adhesive | Not available |
| Biocompatibility | Established biocompatible<br>materials | ISO 10993 - Part 5<br>ISO 10993 - Part 10 | Established biocompatible<br>materials |