(74 days)
The DeRoyal Industries Inc., Surgical Eye Spear is indicated for use in ophthalmic or microscopic surgical procedures to absorb fluids from the operative field.
The DeRoyal Industries Inc., Surgical Eye Spear is to be used to absorb fluids from the operative field during ophthalmic and microscopic surgical procedures.
The DeRoyal Industries, Inc., Surgical Eye Spear functions in the same manner as predicate devices in that it is comprised of an absorbent spear attached to a plastic handle.
Device Design/Materials Used Physical Properties: The DeRoyal Industries, Inc., Surgical Eye Spear is made of materials commonly used in predicate devices. The spear is comprised of cellulose and the handle is made of a high density plastic.
The provided 510(k) summary for the DeRoyal Industries, Inc., Surgical Eye Spear primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria. This type of submission relies on comparative data for device characteristics and biocompatibility testing to show safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific quantitative performance metrics in a clinical study. Instead, acceptance is based on demonstrating the device is substantially equivalent to a legally marketed predicate device. The performance is assessed by comparing key characteristics and materials. Biocompatibility tests have acceptance criteria (e.g., "All test results were deemed acceptable"), but specific numerical thresholds are not provided in this summary.
| Characteristic / Test | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance (DeRoyal Surgical Eye Spear) |
|---|---|---|
| Functional Equivalence | Same function as predicate | Functions in the same manner as predicate devices to absorb fluids. |
| Sponge Material | Same as predicate (Cellulose) | Cellulose |
| Handle Material | Same as predicate (High Density Polyethylene) | High Density Polyethylene |
| Shape | Same as predicate (Triangular Sponge Head) | Triangular Sponge Head |
| Sponge Tip Measurements | Approximately same as predicate | 11/16 inch (length), 9/32 inch (width) |
| Plastic Handle Measurements | Approximately same as predicate | 2-3/16 inch (length), .092-.125 inch (diameter) |
| Sizes | Same as predicate (One Size) | One Size |
| Sterility | Sterile, SAL 10⁻⁶, compliant residue levels | Sterile, Ethylene Oxide with SAL of 10⁻⁶, meets proposed maximum residual limits |
| Biocompatibility (Cytotoxicity) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Sensitization) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Intraocular Irritation) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Systemic Injection) | Acceptable per ISO 10993-1 & USP Class VI | Deemed acceptable |
| Biocompatibility (Hemolysis) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Intracutaneous Toxicity) | Acceptable Per USP Class VI | Deemed acceptable |
| Biocompatibility (Intracutaneous Implantation) | Acceptable Per USP Class VI | Deemed acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Data was not required for this submission." This means there was no clinical test set for evaluating device performance in a real-world scenario (e.g., on human patients). The "test set" for demonstrating substantial equivalence was effectively the predicate device's specifications and the results of the specified bench-top and in-vitro biocompatibility tests.
- Sample Size for Test Set: Not applicable for clinical performance. For biocompatibility, the number of samples used for each test is not specified, but the tests were performed "to assure the safety and biocompatibility."
- Data Provenance: The biocompatibility tests would have been performed in a laboratory setting (in-vitro and in-vivo animal models for some tests like systemic injection). The country of origin for these lab tests is not specified. The data is retrospective in the sense that it refers to tests performed on the device or its materials, not ongoing clinical observations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical data was required, there was no "ground truth" to establish from expert consensus regarding clinical performance. For the biocompatibility tests, the "ground truth" is established by the validated methodologies and acceptance criteria outlined in the referenced standards (ISO 10993-1, USP Class VI). The experts involved would be the certified laboratory personnel performing and interpreting these tests, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring adjudication of outcomes by experts. The biocompatibility test results would be interpreted against established standards by laboratory staff.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document states "Clinical Data was not required for this submission." This type of study would involve human readers (e.g., surgeons) evaluating cases with and without AI assistance, which is outside the scope of this conventional medical device submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. This device is a physical surgical tool, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.
7. The Type of Ground Truth Used
The primary "ground truth" used for this submission is:
- Predicate Device Specifications: The established characteristics and performance of the legally marketed predicate device (Ultracell Medical Technologies K923922).
- Biocompatibility Standards: The established scientific and regulatory standards for biocompatibility (ISO 10993-1, USP Class VI) which serve as the "ground truth" for determining if the device materials are safe for biological contact.
8. The Sample Size for the Training Set
Not applicable. This device is a physical, non-software/AI product. There is no "training set" in the context of machine learning or AI. The design and manufacturing process are informed by general engineering principles and existing product knowledge.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for one. The "ground truth" for the device's design is the established practice and safety profile of the predicate device and the materials used in current medical devices.
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DeRoyal Industries, Inc. Surgical Eye Spear
510(k) Summarv
SEP 3 0 1997
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
DeRoyal Industries, Inc. TELEPHONE: NAME: CONTACT: 200 DeBusk Lane ADDRESS: DATE OF PREPARATION: Powell, TN 37849
(423) 938-7828 Camille Matlock September 19, 1997
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known):
DeRoyal Industries, Inc., Surgical Eye Spear Eve Spear Sponge, Ophthalmic (86HOZ)
PREDICATE OR LEGALLY MARKETED DEVICE
Ultracell Medical Technologies (K923922)
DEVICE DESCRIPTION
The DeRoyal Industries, Inc., Surgical Eye Spear functions in the same manner as predicate devices in that it is comprised of an absorbent spear attached to a plastic handle.
Device Design/Materials Used Physical Properties: The DeRoyal Industries, Inc., Surgical Eye Spear is made of materials commonly used in predicate devices. The spear is comprised of cellulose and the handle is made of a high density plastic.
Clinical Data was not required for this submission.
DEVICE INTENDED USE
The DeRoyal Industries, Inc., Surgical Eye Spear is indicated for use in ophthalmic or microscopic surgical procedures to absorb fluids from the operative field.
| Characteristics & Materials | DeRoyal Surgical Eye Spear | Predicate Device |
|---|---|---|
| Sponge Material | Cellulose | Same |
| Handle Material | High Density Polyethylene | Same |
| Shape | Triangular Sponge Head | Same |
| Sponge Tip Measurements | 11/16 inch (length)9/32 inch (width) | ~Same |
| Plastic Handle Measurements | 2-3/16 inch (length).092 inch - .125 inch (diameter) | ~Same |
| Sizes | One Size | Same |
| Sterility | Sterile | Same |
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STERILITY INFORMATION
The device shall be offered sterile. The method of sterilization is Ethylene Oxide with a Sterility Assurance Level of 10°. The maximum levels of residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol allowed to remain on the device will meet the proposed maximum residual limits stated in the Federal Register, June 23, 1978.
BIOCOMPATIBILITY TESTING
The following Biocompatibility tests were performed. All test results were deemed acceptable.
| TEST | REFERENCE |
|---|---|
| Cytotoxicity | ISO 10993-1 |
| Sensitization | ISO 10993-1 |
| Intraocular Irritation | ISO 10993-1 |
| Systemic Injection | ISO 10993-1 &USP Class VI |
| Hemolysis | ISO 10993-1 |
| Intracutaneous Toxicity | USP Class VI |
| Intracutaneous Implantation | USP Class VI |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of four abstract human profiles facing right, arranged in a stacked, overlapping manner. The profiles are black, and the text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1997
Ms. Camille Matlock Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849
Re: K972693
Trade Name: DeRoyal Industries, Inc. Surgical Eye Spear Regulatory Class: II Product Code: 86 HOZ Dated: July 17, 1997 Received: July 18, 1997
Dear Ms. Matlock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Camille Matlock
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
6912693
Device Name:
DeRoyal Industries Inc., Surgical Eye Spear
Indications for Use:
The DeRoyal Industries Inc., Surgical Eye Spear is to be used to absorb fluids from the operative field during ophthalmic and microscopic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W. C. Brown
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K912693
Image /page/4/Picture/11 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR § 801.109)". There is a signature to the right of the text. The signature is written in cursive and is difficult to read.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.