(252 days)
Not Found
No
The summary describes a physical, disposable device for hemostasis and does not mention any software, algorithms, or AI/ML terms.
No
The device, a disposable angio-closure pad, is used to "assist in obtaining and maintaining hemostasis," which is a supportive rather than a therapeutic function. Therapeutic devices are typically those that treat or cure a disease or condition.
No
Explanation: The device is described as assisting in obtaining and maintaining hemostasis, which is a therapeutic function, not a diagnostic one. It doesn't identify or analyze a medical condition.
No
The device description explicitly lists physical components made of medical-grade materials (Polyurethane, adhesive tape, Polycarbonate), indicating it is a hardware 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 "to assist in obtaining and maintaining hemostasis." This describes a physical intervention to stop bleeding, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details physical components (compression bulb, band, infusion mouth) made of medical-grade materials. This aligns with a medical device used for physical treatment, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for a therapeutic or supportive purpose (hemostasis) rather than a diagnostic one.
N/A
Intended Use / Indications for Use
The SunmedTM disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 following tests were performed on the SunmedTM angio-closure pads:
Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test(two kinds of solvent) Skin sensitization Test (two kinds of solvent) Intracutaneous Reactivity Test (two kinds of solvent) In Vitro Cytotoxicity Test Bacterial endotoxins test
Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing Bench Testing
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.
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
§ 870.4450 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 16, 2020
Sunny Medical Device (Shenzhen) Co.,Ltd. James Zhang General Manager 56 Lehigh Aisle Irvine, California 92612
Re: K191827
Trade/Device Name: SunmedTM Disposable Angio-Closure Pads Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: July 8, 2019 Received: July 8, 2019
Dear James Zhang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachel Neubrander, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191827
Device Name
Sunmed disposable angio-closure pads
Indications for Use (Describe)
The Sunmed disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.
| 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
5. 510(k) Summary
| 1. | Submitted by: | Sunny Medical Device (Shenzhen) Co., Ltd. |
|---|---|---|
| Registered Address: | 1/F and 401, Zhongtianxin Building B, | |
| Longgang District, Shenzhen, | ||
| Guangdong, P.R. China 518172 | ||
| Contact Address: | 11630 Wilkins Ave, APT # 104 | |
| Los Angeles, CA 90024 | ||
| USA | ||
| Telephone: | (949)216-8838 | |
| Fax: | (949) 423-0168 | |
| Contact: | JamesQi Zhang, General Manager | |
| E-mail: | jamesqizhang@gmail.com | |
| Date: | Mar 7, 2020 |
-
- Proposed Device:
| Trade/Proprietary Name: | SunmedTM disposable angio-closure pads |
|---|---|
| Common/Usual Name: | disposable angio-closure pads |
| Classification: | II |
| ClassificationName: | Clamp, Vascular |
| Regulation Number: | 870.4450 |
| Product Code: | DXC |
-
- Predicate Device:
| 510(k)
| Number | Trade Name | Manufacture |
|---|---|---|
| K062569 | Safeguard™ 24cm pressure | |
| assisted dressing | Datascope Corp. |
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4. Device description
disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.
-
- Intended Use
The Sunmed™ disposable angio-closure pads is to assist in obtaining and maintaining hemnostasis.
- Intended Use
-
- Technological Comparison to Predicate Device
The technological characteristics of the subject device, The Sunmed™ disposable angio-closure pads, are equivalent to the Safeguard™ 24cm pressure assisted dressing in terms of intended use, fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.
- Technological Comparison to Predicate Device
-
- Summary of Non-Clinical Testing
The following tests were performed on the Sunmed™ angio-closure pads:
- Summary of Non-Clinical Testing
Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test(two kinds of solvent) Skin sensitization Test (two kinds of solvent) Intracutaneous Reactivity Test (two kinds of solvent) In Vitro Cytotoxicity Test Bacterial endotoxins test
Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing Bench Testing
-
- Clinical Evaluation was not applicable.
-
- Conclusions
Based on the information presented in this 510(k) premarket notification, the Sunmed™ disposable angio-closure pads is considered substantially equivalent to the Safeguard™ 24cm pressure assisted dressing.