(121 days)
Not Found
Not Found
No
The summary describes replacement surgical blades and does not mention any AI or ML capabilities.
Yes
The blades are used for lamellar resection of the cornea, which is a therapeutic intervention.
No
The device is a replacement blade for a surgical system used for "lamellar resection of the cornea," indicating a therapeutic rather than diagnostic purpose.
No
The 510(k) summary describes replacement blades for a surgical system, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "FOR LAMELLAR RESECTION OF THE CORNEA". This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: While not found, the intended use clearly points to a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical blade used during a surgical procedure.
N/A
Intended Use / Indications for Use
SURGIN'S PRIZM BLADES ARE INTENDED AS REPLACEMENT BLADES FOR THE “BECTON DICKINSON BD - 3000 MICROTOME SHALLOW SYSTEM", TO BE USED FOR LAMELLAR RESECTION OF THE CORNEA
Product codes
HNO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
CORNEA
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)
Not Found
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.
Not Found
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
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgin, Inc. c/o Don Harr RA/OA Manager 14762 Bentley Circle Tustin, CA 92680
Re: K033182
Trade/Device Name: PRIZM Keratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: December 16, 2003 Received: January 5, 2004
Dear Mr. Harr:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have a rowed your 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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drag, 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 r our may, merere, mans of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is exactive (tional controls. Existing major regulations affecting your device can may or subject to back as 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 cquivalence determination does not mean I lease be actised that I Dr vistian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny redorm statutes the requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quand cyerol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
JAN 30 2004
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Page 2 - Don Harr
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Alegi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Surgin, Inc 14762 Bentley Circle Tustin, CA 92680 Tel: 714 832 6300
INDICATIONS FOR USE STATEMENT
K033182 510(k) Number (il known): Device Name: Purzu Barac Indications For Use: SUREN'S PM BUNDES AND DESIGNATI AS NEPLACEMENT Burdes For 7 The BESTON DICKINSON BD - 3000 MICH SHATUALE SYSTEM", To BE USED FOR CANECLAR PESEGENON OF THE CORNEA
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrance of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Ophthalmic Ear, Nose and Throat Devices | ||
| 510(k) Number | K033182 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)