(116 days)
No
The summary describes a standard ultrasound imaging system for ophthalmic applications and does not mention any AI or ML capabilities. The performance studies and device description focus on traditional ultrasound measurements and imaging.
No
The device is used for diagnostic purposes (measurement and imaging) and does not perform any therapeutic intervention or treatment.
Yes.
The device performs measurements (axial length, corneal thickness) and imaging (ocular ultrasound imaging) of the eye, which are used by doctors to diagnose conditions. The "Intended Use / Indications for Use" section states it can be used for "ophthalmology clinical application" and the "Device Description" details various models that perform "biometric measurement" and "ocular ultrasound imaging," all of which gather data for diagnostic purposes.
No
The device description explicitly mentions "A, P, B probes" and describes their function in transmitting and receiving ultrasound waves, indicating the presence of hardware components beyond just software.
Based on the provided information, the Sunkingdom Ophthalmic Ultrasound Examination Instrument is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Sunkingdom Ophthalmic Ultrasound Examination Instrument uses ultrasound waves to directly examine the eye in vivo (within the living body). It measures anatomical structures (axial length, corneal thickness) and creates images of the eye.
- No Specimen Analysis: The device does not analyze any biological specimens removed from the patient.
Therefore, the Sunkingdom Ophthalmic Ultrasound Examination Instrument is a medical device used for diagnostic imaging and measurement in vivo, not an IVD.
N/A
Intended Use / Indications for Use
Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement; and B-scan echography applies to ocular ultrasound imaging.
The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis etc);and this device cannot be used on fetuses.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
Sunkingdom Ophthalmic Ultrasound Examination Instrument, models SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is an ultrasound imaging system intended for use in ophthalmic applications.
Model SK-3000A with A, P, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length), corneal thickness and to ocular ultrasound imaging.
Model SK-3000B with A, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and to ocular ultrasound imaging.
Model SK-3000C with B probe is used to ocular ultrasound imaging.
Model SK-2000AP with A, P probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and corneal thickness.
Model SK-2000A with A probe is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length).
Model SK-2000P with P probe is used to biometric measurement of corneal thickness.
Among them, the 10 MHz A probe transmits ultrasound wave into eye tissue, and measure the duration of the acoustic pulse from the A probe to anterior chamber, lens and vitreum and back to the A probe. This mode is mainly used for biometric measurement axial length, which including anterior chamber depth, lens thickness, vitreous depth of eyes.
The 10 MHz B probe transmits ultrasound wave into eye tissue, and to form a sectional echogram by means of the brightness of echogenic dots. This mode is mainly used for ocular ultrasound imaging.
The 20 MHz Pachymeter probe is to get the thickness of corneal by measurement of the time interval between the anterior and posterior interface reflection waves of cornea. This mode is mainly used for biometric measurement of corneal thickness.
All probes can work independently, and record patient data and connect to a video printer to print image report. It also can work with computer which has the software installed to manage patient record.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ocular
Indicated Patient Age Range
Not Found (explicitly states "this device cannot be used on fetuses")
Intended User / Care Setting
The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics.
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)
Performance Data:
Biocompatibility testing:
- In Vitro Cytotoxicity
- Irritation
- Skin Sensitization
Results: The extract of applied sample is not cytotoxic. No obvious evidence of skin sensitization was observed.
Electromagnetic compatibility and electrical safety testing:
- ANSI AAMI IEC 60601- 1-2:2014
- ANSI AAMI ES 60601- 1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/ (R) 2012
- IEC 60601-2-37: 2007 + AMD1:2015
Acoustic output testing:
- Followed Track 1 recommendations for diagnostic ultrasound systems and transducers as per FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued on July 27, 2019.
Software Verification and Validation:
- Software and cybersecurity passed verification and validation program. Results comply with requirements.
Conclusions: Devices are in compliance with FDA recognized standards, safe and effective, and substantially equivalent to the main predicate device MEDA Ultrasonic A/B Scanner (K063433).
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.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 9, 2023
Chongqing Sunkingdom Medical Instrument Co., Ltd. % Shulin Guo Registration manager 1010, Block A of China Resource Center No.55 of XieJiaWan JiuLongPo Chongaing, 400050 CHINA
Re: K222787
Trade/Device Name: Sunkingdom Ophthalmic Ultrasound Examination Instrument: SK-3000A. SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: September 1, 2022 Received: December 8, 2022
Dear Shulin Guo:
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,
Yanna S. Kang -S
Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222787
Device Name
Sunkingdom Ophthalmic Ultrasound Examination Instrument: SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
Indications for Use (Describe)
Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement; and B-scan echography applies to ocular ultrasound imaging.
The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis etc);and this device cannot be used on fetuses.
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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510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with 21 CFR 807.92.
| Submitter (510K Owner): | Chongqing Sunkingdom Medical Instrument Co., Lt
35-2, YingTian GuangDian GongGu, CaiJiaGang
Industrial Zone, BeiBei District, Chongqing, China
Contact Person: Shulin Guo
Phone: +86-23-68643990
Fax: +86-23 -68677919
E-Mail: regist01@cqsunkingdom.com
Registration #: 3010610157 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dayna Valente
83 Gerber RD West South Windsor
Connecticut, 06074, USA
Phone: (860)6484906
Fax: (860) 6484906 |
| Date of Preparation: | August 25th, 2022 |
| Proprietary Name: | Sunkingdom Ophthalmic Ultrasound Examination
Instrument SK-3000A, SK-3000B, SK-3000C,
SK-2000AP, SK-2000A, SK-2000P |
| Common or Usual Name: | Ultrasonic pulsed echo imaging system |
| Classification Name: | System, Imaging, Pulsed Echo, Ultrasonic
21CFR 892.1560, 21CFR 892.1570
Class II |
| Product Code: | IYO, ITX |
| Review Panel: | Radiology |
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Predicate Devices
| Main predicate device | ODM-2100 & ODM-2200 Ultrasonic A/B
Scan system for Ophthalmology |
|-----------------------|---------------------------------------------------------------------|
| Manufacturer | MEDA CO., LTD |
| K# | K063433 for 10MHz A scan and 10MHz B scan |
| Reference device | MD- 1000P Ultrasonic Pachymeter |
|---|---|
| Manufacturer | MEDA CO., LTD |
| K# | K121243 for 20MHz P scan |
Intended Use/ Indication for use
Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement;and B-scan echography applies to ocular ultrasound imaging.
The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc);and this device cannot be used on fetuses.
Device Description
Sunkingdom Ophthalmic Ultrasound Examination Instrument, models SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is an ultrasound imaging system intended for use in ophthalmic applications.
Model SK-3000A with A, P, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length), corneal thickness and to ocular ultrasound imaging.
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Model SK-3000B with A, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and to ocular ultrasound imaging.
Model SK-3000C with B probe is used to ocular ultrasound imaging.
Model SK-2000AP with A, P probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and corneal thickness.
Model SK-2000A with A probe is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length).
Model SK-2000P with P probe is used to biometric measurement of corneal thickness.
Among them, the 10 MHz A probe transmits ultrasound wave into eye tissue, and measure the duration of the acoustic pulse from the A probe to anterior chamber, lens and vitreum and back to the A probe. This mode is mainly used for biometric measurement axial length, which including anterior chamber depth, lens thickness, vitreous depth of eyes.
The 10 MHz B probe transmits ultrasound wave into eye tissue, and to form a sectional echogram by means of the brightness of echogenic dots. This mode is mainly used for ocular ultrasound imaging.
The 20 MHz Pachymeter probe is to get the thickness of corneal by measurement of the time interval between the anterior and posterior interface reflection waves of cornea. This mode is mainly used for biometric measurement of corneal thickness.
All probes can work independently, and record patient data and connect to a video printer to print image report. It also can work with computer which has the software installed to manage patient record.
This device must be used by trained and qualified medical personnel.
Contraindication: Patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc) and the fetal cannot use the device.
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Technological characteristics
B mode:
Nominal frequency: 10MHz Detection depth: ≥50mm Lateral Resolution: ≤ 0.4mm Axial resolution: ≤0.2mm Horizontal geometric position accuracy: ≤ 10% Vertical geometric location accuracy: ≤5% Blind zone: