(57 days)
Not Found
No
The device description focuses on mechanical components and adjustable compression, with no mention of AI/ML terms or functionalities.
Yes
The device is described as promoting hemostasis and is used for patients following catheterization or other punctures, which are therapeutic medical interventions.
No
The device is described as promoting hemostasis and applying compression, which are therapeutic functions, not diagnostic ones. Its purpose is to stop bleeding, not to identify a disease or condition.
No
The device description clearly outlines physical components like a flexible thermoplastic base, adhesive pads, and a plunger with a ratcheting mechanism, indicating it is a hardware device.
Based on the provided information, the VasoStat™ Hemostasis Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or lower leg." This is a direct intervention on the patient's body to stop bleeding.
- Device Description: The device is described as being "adhered to the patient's skin directly over a percutaneous vascular puncture site and allows the application of adjustable compression to the puncture site to achieve hemostasis." This is a mechanical device applied externally to the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The VasoStat™ device does not perform any tests on samples.
The VasoStat™ Hemostasis Device is a mechanical device used for external compression to achieve hemostasis, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes
DXC
Device Description
VasoStatTM Hemostasis Device is a device that is adhered to the patient's skin directly over a percutaneous vascular puncture site and allows the application of adjustable compression to the puncture site to achieve hemostasis. The device is composed of a flexible thermoplastic base that has the ability to conform to the patient's anatomy (e.g. lower arm, upper arm, foot) and is secured to the skin with biocompatible adhesive pads. A plunger component passes through the base, applies targeted pressure to the puncture site through a ratcheting mechanism, and can be adjusted with one hand to apply the appropriate pressure necessary to promote hemostasis. VasoStat has the ability to vary the amount of pressure applied to the puncture site to promote hemostasis while minimizing the risk of thrombosis. The device design and materials ensure that the product is comfortable for the patient to wear while their puncture site stops bleeding. Once hemostasis is achieved (in approximately 15 to 45 minutes), the device is easily removed and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm or lower leg, radial artery, pedal or tibial artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
The VasoStat™ Hemostasis Device was retrospectively evaluated in three-hundred fourteen (314) patients following transpedal access for peripheral vascular disease intervention. The analysis concluded that the VasoStat™ Hemostasis Device was capable of achieving hemostasis following transpedal catheterization with low rates of pseudo-aneurysm and access site occlusion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a triple-stranded helix, resembling a stylized bird in flight. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.
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.
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" (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 (800) 638-2041 or (301) 796-7100 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
2
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) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Submitter Name: | Forge Medical, Inc |
|---|---|
| Submitter Address: | 791 West Broad Street, Suite 102 |
| Bethlehem, PA 18018 | |
| Phone Number: | |
| Fax Number: | 215-605-3225 |
| 866-244-8988 | |
| Contact Person: | Mason Diamond, DDS |
| Texel Fortis, LLC | |
| 150 Levinberg Lane | |
| Wayne, NJ 07470 | |
| Phone: 508-333-0108 | |
| Fax: 973-305-0213 | |
| Date Prepared: | 10 December, 2015 |
| Device Trade Name: | VasoStatTM Hemostasis Device |
| Common Name | Vascular compression device |
| Classification Name | |
| Number and | |
| Product Code: | Vascular clamp |
| 870.4450 | |
| DXC | |
| Predicate Devices: | VasoStatTM Hemostasis Device (Forge Medical): K123041 |
| RadARTM Vascular Compression Assist Devices (Advanced | |
| Vascular Dynamics): K142122 | |
| Device Description | VasoStatTM Hemostasis Device is a device that is adhered to the |
| patient's skin directly over a percutaneous vascular puncture site | |
| and allows the application of adjustable compression to the | |
| puncture site to achieve hemostasis. The device is composed of | |
| a flexible thermoplastic base that has the ability to conform to the | |
| patient's anatomy (e.g. lower arm, upper arm, foot) and is secured | |
| to the skin with biocompatible adhesive pads. A plunger | |
| component passes through the base, applies targeted pressure to | |
| the puncture site through a ratcheting mechanism, and can be | |
| adjusted with one hand to apply the appropriate pressure | |
| necessary to promote hemostasis. VasoStat has the ability to vary | |
| the amount of pressure applied to the puncture site to promote | |
| hemostasis while minimizing the risk of thrombosis. The device | |
| Submitter: | |
| Forge Medical, Inc. | VasoStat™ Hemostasis Device |
| Premarket Notification: Traditional 510(k) | |
| design and materials ensure that the product is comfortable for | |
| the patient to wear while their puncture site stops bleeding. Once | |
| hemostasis is achieved (in approximately 15 to 45 minutes), the | |
| device is easily removed and discarded. | |
| Statement of | |
| Indications for 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. | |
| Summary of | |
| Technological | |
| Characteristics | The VasoStat™ Hemostasis Device is designed to provide local |
| compression to the puncture site into a blood vessel of the arm or | |
| lower leg, including arterial sheath placement and dialysis shunt | |
| access. The degree of pressure is designed to stop bleeding | |
| without causing vessel thrombosis. The VasoStat™ Hemostasis | |
| Device is the same as that previously cleared by the FDA | |
| (K123041), and functions in the same way. Though different in | |
| design, the VasoStat™ Hemostasis Device provides sufficient | |
| compression to stop bleeding in pedal arterial catheterizations | |
| similar to the RadAR™ Vascular Compression Assist Devices, | |
| which also utilize compression to stop bleeding (K142122). | |
| Performance | |
| Testing | Since this submission applies to the VasoStat™ Hemostasis |
| Device to revise the indications for use without any changes to | |
| device design, the benchtop and animal testing reported in | |
| K123041 has been leveraged to demonstrate that the submitted | |
| device is appropriate for the new indications for use. Similarly, | |
| biocompatibility for this device has already been established per | |
| ISO-10993 (K123041). |
Furthermore, the VasoStat™ Hemostasis Device was
retrospectively evaluated in three-hundred fourteen (314) patients
following transpedal access for peripheral vascular disease
intervention. The analysis concluded that the VasoStat™
Hemostasis Device was capable of achieving hemostasis
following transpedal catheterization with low rates of pseudo-
aneurysm and access site occlusion. |
| Substantial
Equivalence | The VasoStat™ Hemostasis Device is Substantially Equivalent to
predicate VasoStat™ Hemostasis Device (K123041), with respect
to technical and design features. The Indications for Use and
Mode of Action is Substantively Equivalent to the RadAR™
Vascular Compression Assist Devices (K142122). |
| Conclusion | The information discussed above demonstrates that the
VasoStat™ Hemostasis Device is substantially equivalent to the
predicate device. |
4
5
Summary of Substantial Equivalence
| Feature | VasoStat™ Hemostasis
Device | VasoStat™ Hemostasis
Device | RadAR™ Vascular
Compression Assist
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
Use | ...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. | ...indicated for use by
medical professionals to
promote hemostasis
following a catheterization
or other puncture into a
blood vessel in a patient's
arm, including radial artery
catheterization, arterial or
venous line removal,
hemodialysis, and in
patients on anticoagulation
therapy. | ...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 leg, including radial
brachial, dorsalis, pedis, or
tibial blood vessels, arterial
or venous line or sheath
removal, hemodialysis, and
in patients on
anticoagulation therapy. |
| Mode of Action | Compression | Compression | Compression |
| Composition | Same a predicate | Molded
Polypropylene/Polyethylen
e Foam/Acrylic Adhesive | Not available |
| Biocompatibility | Established biocompatible
materials | ISO 10993 - Part 5
ISO 10993 - Part 10 | Established biocompatible
materials |