(243 days)
No
The device description focuses on mechanical compression and does not mention any computational or data-driven components.
Yes
The device is used to promote hemostasis following a puncture into a blood vessel, which is a direct treatment for a bodily condition, aligning with the definition of a therapeutic device.
No.
The device's intended use is to promote hemostasis following a catheterization or other puncture, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (flexible thermoplastic base, plunger, adhesive pads) and a mechanical mechanism (ratcheting mechanism) for applying pressure. This indicates a hardware-based device, not a software-only one.
Based on the provided information, the VasoStat™ Hemostasis Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is used to promote hemostasis (stop bleeding) following a puncture into a blood vessel. This is a direct intervention on the patient's body.
- Device Description: The description details a physical device that applies pressure to a puncture site. It does not involve the analysis of biological samples (like blood, urine, or tissue) outside of the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The VasoStat™ does not perform this function.
The VasoStat™ Hemostasis Device is a medical device used for a therapeutic purpose (promoting hemostasis).
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, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.
Product codes
DXC
Device Description
The VasoStat™ Hemostasis Device is an ergonomic, simple 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, etc.) and is secured to the skin with biocompatible, hypoallergenic 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
patient's arm
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
A domestic swine model was utilized for in vivo assessment of the VasoStat™ Hemostasis Device in comparison to the Terumo TR Band (predicate device). Vascular sheaths were created in the femoral arteries and veins, and in the jugular veins. The sheaths were removed and either a VasoStat™ Hemostasis Device or a Terumo TR Band placed. Both devices achieved hemostasis in the approximately 5.8 minutes (average). These results demonstrate that the VasoStat™ Hemostasis Device and the predicate device are substantially equivalent.
Biocompatibility testing (per ISO 10993) performed on the device demonstrated, that the VasoStat Hemostasis Device is safe for the indications of use, and was found to be non-cytotoxic, nonreactive and non-sensitizing by ISO Cytotoxicity, ISO Intracutaneous Reactivity and ISO Buehler Sensitization testing, respectively.
Key Metrics
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
Submitter: Forge Medical, Inc.
VasoStat™ Hemostasis Device Premarket Notification: Traditional 510(k)
MAY 2 9 2013
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
510(k) Summary
| Submitter Name: | Forge Medical, Inc |
|---|---|
| Submitter Address: | 8516 Parkwood Lane |
| Philadelphia, PA 19128 | |
| Phone Number: | 877-466-0109 |
| Fax Number: | 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: | 30 April, 2013 |
| Device Trade Name: | VasoStat™ Hemostasis Device |
| Common Name | Vascular compression device |
| Classification Name | Vascular clamp |
| Number and | |
| Product Code: | 870.4450 |
| DXC | |
| Predicate Devices: | RaDAR Vascular Compression Device (Advanced Vascular |
| Dynamics) (DXC): K092503 | |
| TR Band (Terumo) (DXC): K070423 | |
| VasoStat™ Hemostasis Device (Forge Medical) (NOO): Device | |
| Listing (D147574) | |
| Device Description | The VasoStat™ Hemostasis Device is an ergonomic, simple |
| 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.
Section 5.0: 510(k) Summary
i
1
lower arm, upper arm, etc.) and is secured to the skin with biocompatible, hypoallergenic 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.
Statement of Indication 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, including radial 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 sites of a dialysis access shunt of a dialysis patient. The device applies uniform pressure to the sites of needle puncture along the dialysis access shunt until hemostasis is achieved. The degree of pressure is designed to stop bleeding without causing blood clots.
A domestic swine model was utilized for in vivo assessment of the VasoStat™ Hemostasis Device in comparison to the Terumo TR Band (predicate device). Vascular sheaths were created in the femoral arteries and veins, and in the jugular veins. The sheaths were removed and either a VasoStat™ Hemostasis Device or a Terumo TR Band placed. Both devices achieved hemostasis in the approximately 5.8 minutes (average). These results demonstrate that the VasoStat™ Hemostasis Device and the predicate device are substantially equivalent.
Biocompatibility testing (per ISO 10993) performed on the device demonstrated, that the VasoStat Hemostasis Device is safe for the indications of use, and was found to be non-cytotoxic, nonreactive and non-sensitizing by ISO Cytotoxicity, ISO Intracutaneous Reactivity and ISO Buehler Sensitization testing, respectively.
The VasoStat™ Hemostasis Device is substantially equivalent to the predicates. RaDAR Vascular Compression Device (K092503), the TR Band (K070423), and the VasoStat™ Hemostasis Device (D147574), with respect to technical and design features. The submitted device poses no new questions about safety or effectiveness as compared to the predicate devices.
Substantial Equivalence
2
| Submitter:
Forge Medical, Inc. | VasoStat™ Hemostasis Device
Premarket Notification: Traditional 510(k) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The information discussed above and presented in the following
table demonstrates that the VasoStat™ Hemostasis Device is
substantially equivalent to the predicate devices. |
| Declarations | • This summary includes only information that is also covered in
the body of the 510(k).
• This summary does not contain any unsubstantiated labeling
claims.
• This summary does not contain any raw data, i.e., contains
only summary data. |
o This summary does not contain any trade secret or confidential commercial, information.
o This summary does not contain any patient identification information.
3
Submitter:
Forge Medical, Inc.
ummary of Substantial Equivalen
| Feature | VasoStat™ Hemostasis Device | RaDAR Vascular Compression Device | TR Band | VasoStat™ Hemostasis Device |
|---|---|---|---|---|
| 510(k) Number | K123041 | K092503 | K070423 | D147574 |
| Class | II | II | II | I (Exempt) |
| Classification | Vascular clamp | Vascular clamp | Vascular clamp | Clamp, Dialysis arm |
| Regulation | 870.4450 | 870.4450 | 870.4450 | 876.5540 |
| Product Code(s) | DXC | DXC | DXC | NOO |
| 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, 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, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy. | ...is a compression device to assist hemostasis of the radial artery after a transradial procedure. | ...to temporarily apply puncture site compression and, aid in obtaining puncture site hemostasis, following the removal of dialysis needles. |
| Mode of Action | Compression | Compression | Compression | Compression |
| In Vivo Performance | Hemostatic | Not Tested | Hemostatic | Hemostatic |
| Composition | Molded | |||
| Polypropylene/Polyethylene Foam/Acrylic Adhesive | Not Available | Plastic | Molded | |
| Polypropylene/Polyethylene Foam/Acrylic Adhesive | ||||
| Biocompatibility | ISO 10993- Part 5 | |||
| ISO 10993- Part 10 | Established biocompatible materials | ISO 10993- Part 5 | ||
| ISO 10993- Part 10 | ISO 10993- Part 5 | |||
| ISO 10993 - Part 10 |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2013
Forge Medical, Inc! c/o Mr. Mason Diamond 150 Levinberg Lane Wayne, NJ 07470
Re: K123041
Trade/Device Name: VasoStat Hemostasis Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: April 10, 2013 Received: April 12, 2013
Dear Mr. Mason 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-interstatecommerce 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
5
Page 2 - Mr. Mason Diamond
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zackerman -S
| Bram D. Zuckerman, M.D. | |
|---|---|
| Director | |
| Division of Cardiovascular Devices | |
| Office of Device Evaluation | |
| Center for Devices and | |
| Radiological Health |
Enclosure
6
Submitter: Forge Medical, Inc.
VasoStat™ Hemostasis Device Premarket Notification: Traditional 510(k)
Indications for Use
510(k) Number (if known): K123041
Device Name: VasoStat™ Hemostasis Device
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, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.
Prescription Use X (Part 21 CFR 801 Subpart D) · AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE-DO NOT-WRITE-BELOW-THIS-LINE-CONTINUE-ON-ANOTHER-PAGE-IF NEEDED)-
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/6/Picture/13 description: The image shows the text "Bram D. Zuckerman -S" on the first line. The second line shows the date and time "2013.05.29 19:10:41". The third line shows the timezone offset "-04'00'". There is also a logo in the image, but it is difficult to make out the details.
Section 4.0