(168 days)
Not Found
No
The device description and performance studies focus on the physical properties and delivery of embolic microspheres, with no mention of AI or ML technologies.
Yes
The device is indicated for embolization of hypervascularized tumors and peripheral arteriovenous malformations, which are medical conditions. The embolization procedure is a form of treatment, thus making the device therapeutic.
No
The device is described as "Embolic Microspheres" used for "embolization of hypervascularized tumors" and "peripheral arteriovenous malformations". Embolization is a therapeutic procedure, not a diagnostic one.
No
The device description clearly states that the device consists of physical microspheres packaged in a bottle, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for embolization of hypervascularized tumors and arteriovenous malformations. This is a therapeutic procedure performed in vivo (within the body) to block blood vessels.
- Device Description: The device is a physical object (microspheres) intended to be delivered into the body through a catheter.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This description does not mention any such use or interaction with patient specimens outside the body.
Therefore, UniPearls® Embolic Microspheres are a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
UniPearls® Embolic Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
Product codes
KRD
Device Description
UniPearls® Embolic Microspheres consist of non-biodegradable hydrogel microspheres packaged in a 10 ml penicillin bottle. The penicilin bottle contains 1 ml of spheres suspended in 7 ml of physiological saline or 2 ml of spheres suspended in 6 ml of physiological saline. UniPearls® Embolic Microspheres are offered in seven sizes: 70μm, 400μm, 500μm, 700μm and 1000μm. The spheres are available in two colors: colorless and blue. The spheres are intended to be used with an inner diameter that is adequate for sphere delivery (not included). The finished by steam and is intended for single use only.
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
Not Found
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
Performance testing, including: Appearance and Size Range, Catheter Deliverability, Compressibility Test, Water Content, Quantity Test, pH Test, Impurities and Residual Solvent, Bacterial Endotoxin, Sterility Test, Sample Size Calculation; animal study, etc. The results of the testing demonstrated that the subject UniPearls® Embolic Microspheres met the pre-determined acceptance critearia applicable to the requirements and performance of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
November 14, 2023
Suzhou Haowei Medical Technology Co., Ltd. Jinyan Shi RA Manager Room 304, Building 4, Tianyun Square, No.111 Wusongjiang Avenue, Guoxiang Street, Wuzhong District, Suzhou Suzhou, Jiangsu 215124 CHINA
Re: K231554
Trade/Device Name: UniPearls® Embolic Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: II Product Code: KRD Received: October 10, 2023
Dear Jinyan Shi:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
Glenn B. Bell -S
Glenn B. Bell, Ph.D. Division Director DHT3A: Division of Renal,Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
indications for
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
UniPearls® Embolic Microspheres
Indications for Use (Describe)
UniPearls® Embolic Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
231554 Da
| 510(k) #: K231554 | 510(k) Summary | |
|---|---|---|
| K231554 Page 1 of 1 | ||
| Prepared on: 2023-10-10 | ||
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Suzhou Haowei Medical Technology Co., Ltd. | |
| Applicant Address | Room 304, Building 4, Tianyun Square, No.111 Wusongjiang Avenue, | |
| Guoxiang Street, Wuzhong District, Suzhou 215124, P.R.China Suzhou | ||
| Jiangsu 215124 China | ||
| Applicant Contact Telephone | +86 0512-663875 | |
| Applicant Contact | Ms. Jinyan Shi | |
| Applicant Contact Email | shijinyan@hiwemed.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | UniPearls® Embolic Microspheres | |
| Common Name | Vascular embolization device | |
| Classification Name | Device, Vascular, For Promoting Embolization | |
| Regulation Number | 870.3300 | |
| Product Code | KRD | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K172372 | QuadraSphere Microspheres | KRD |
| Device Description Summary | 21 CFR 807.92(a)(4) |
Device Description Summary
UniPearls® Embolic Microspheres consist of non-biodegradable hydrogel microspheres packaged in a 10 ml penicillin bottle. The penicilin bottle contains 1 ml of spheres suspended in 7 ml of physiological saline or 2 ml of spheres suspended in 6 ml of physiological saline. UniPearls® Embolic Microspheres are offered in seven sizes: 70μm, 400μm, 500μm, 700μm and 1000μm. The spheres are available in two colors: colorless and blue. The spheres are intended to be used with an inner diameter that is adequate for sphere delivery (not included). The finished by steam and is intended for single use only.
Intended Use/Indications for Use
UniPearls® Embolic Microspheres are indication of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
Indications for Use Comparison
The indications for use of the subject device are the same as those of the predicate device.
Technological Comparison
UniPearls® Embolic Microspheres are similar in intended use, design, and principles of operation to the predicate devices
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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are sterile, intended to be delivered with contrast through a catheter to promote targeted vessel embolization.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing, including: Appearance and Size Range, Catheter Deliverability, Compressibility Test, Water Content, Quantity Test, pH Test, Impurities and Residual Solvent, Bacterial Endotoxin, Sterility Test, Sample Size Calculation; animal study, etc. The results of the testing demonstrated that the subject UniPearls® Embolic Microspheres met the pre-determined acceptance critearia applicable to the requirements and performance of the device.