(54 days)
No
The device description and performance studies focus on the physical properties and absorption capabilities of a simple surgical tool, with no mention of AI or ML.
No
The device is described as absorbing fluids and removing debris during surgery, which are functions of a surgical aid, not a therapeutic intervention to treat a disease or condition.
No
The device is designed to absorb fluids and remove debris during ophthalmic surgery, which are therapeutic and operational functions, not diagnostic.
No
The device description clearly states it is a physical, single-use device made of material designed to absorb fluids and remove debris, with different models based on size and configuration of a plastic handle. It also mentions sterilization and physical property testing, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery." This describes a physical action performed during a surgical procedure, not a test performed in vitro (outside the body) on a specimen to provide diagnostic information.
- Device Description: The description focuses on the physical characteristics and function of the device (absorbing fluids, removing debris). It doesn't mention any components or processes related to analyzing biological samples or providing diagnostic results.
- Performance Studies: The performance studies described are focused on the physical properties of the device (absorbency, sterility, biocompatibility, seal strength, etc.) and its ability to perform its intended function during surgery. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Eye Spears do not perform this function. They are surgical accessories used to manage the surgical field.
N/A
Intended Use / Indications for Use
The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
Product codes
HOZ
Device Description
SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle.
They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
operative field during ophthalmic surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM FI140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
ASTM F1929-12, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
BS EN 13726-1: 2002, Test methods for primary wound dressings -Part 1: Aspects of absorbency USP 35-NF30:2012, Bacterial Endotoxins Test.
USP 35-NF30:2012, Particulate Matter in Ophthalmic Solutions
And following physical properties tests were conducted: absorption capacity, release of particulates, wicking rate. pore size, dry density, pH and formaldehyde residues in aqueous extracts, mechanical strength of sponge-handle attachment, and visual inspection for rough edges. The test results demonstrated that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
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
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
510(k) Summary
ﺎﺭ ﮨﮯ
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
K132796 The assigned 510(k) Number: _
- Date of Submission: 08/20/2013 1.
OCT 3 0 2013
- Sponsor Identification 2.
Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China.
Establishment Registration Number: 3007735241
Contact Person: Wei Lu Position: Development Engineer Tel: 86 752 530201 3 Fax: 86 752 5302020 Email: wlu@foryougroup.com
- Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 . Email: info@mid-link.net
1
-
- Proposed Device Identification
Proposed Device Name: SUNTOUCH® Eye Spear Proposed Device Model: ES1001A-P, ES1001A-P, ES1002A-B, ES1002A-P, ES1002A-P, ES1002B, ES1003B
- Proposed Device Identification
Proposed Device Common Name: Eye Spear
Regulatory Information: Classification Name: Sponge, Ophthalmic; Classification: II; Product Code: HOZ; Regulation Number: 886.4790; Review Panel: Ophthalmic;
Intended Use Statement: The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
-
- Predicate Device Identification
510(k) Number: K002279 Product Name: ML Eye Spear Manufacturer: Med-Logics, Inc
- Predicate Device Identification
-
Device Description 6.
SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle.
They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin 3-2
2
sensitization.
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM FI140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
ASTM F1929-12, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
BS EN 13726-1: 2002, Test methods for primary wound dressings -Part 1: Aspects of absorbency USP 35-NF30:2012, Bacterial Endotoxins Test.
USP 35-NF30:2012, Particulate Matter in Ophthalmic Solutions
And following physical properties tests were conducted: absorption capacity, release of particulates, wicking rate. pore size, dry density, pH and formaldehyde residues in aqueous extracts, mechanical strength of sponge-handle attachment, and visual inspection for rough edges. The test results demonstrated that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | HOZ | Same |
| Regulation Number | 21 CFR 886.4790 | Same |
| Intended Use | The Eye Spears are designed to absorb fluids and | |
| remove debris from the operative field or | ||
| instruments during ophthalmic surgery. | Same | |
| Configuration | Expansive sponge and plastic handle | Same |
| Performance | Absorbency tested per BS EN 13726-1 | |
| Microscopic Particle Count tested per USP | Similar | |
| Material | Expansive sponge: PVA | Same |
| Handle: PP | Same | |
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10. | Same |
| Single Use | Yes | Same |
| Sterilization | Method: Radiation | |
| SAL: 10-6 | Same | |
| Shelf Life | 5 years | Same |
| Label and Labeling | Meet FDA's Requirements | Same |
Table 3-1 Comparison of Technology Characteristics
3
The proposed device, SUNTOUCH® Eye Spear, is determined to be Substantially Equivalent (SE) to the predicate device(s), ML Eye Spear (K002279), in respect of safety and effectiveness.
.
.
.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
October 30, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Huizhou Foryou Medical Devices Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. BOX 120-119. Shanghai, 200120, China
Re: K132796 Trade/Device Name: Suntouch® Eye Spear Regulation Number: 21 CFR 886.4790 Regulation Name: Sponge, Ophthalmic Regulatory Class: Class II Product Code: HOZ Dated: August 28, 2013 Received: September 6, 2013
Dear Ms. Hong:
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.
5
Page 2 - Ms. Diana Hong
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" (21 CFR 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,
Deborah L. Falls -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K132796
Device Name: Device Name: SUNTOUCH® Eye Spear
Indications for Use:
The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
Prescription Use_ × (part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center of Devices and Radiological Health (CDRH)
| Leonid Livshitz-S |
|---|
| 2013:10:24 |
| '00'04-09:17:34 |
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________
page 1 of ____________________________________________________________________________________________________________________________________________________________________