(178 days)
The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.
The microkeratome blades are manufactured either with a prefixed plastic post or have a slot/holes in the blade. The plastic post fits into a slot within the microkeratome instrument and the slot/holes in the blade are used to affix the blades to a stainless steel post on the microkeratome. The steel used for the blade in either configuration is the same, as well as the packaging and sterilization method. The blades are designed to be used in pre-existing, on the market, microkeratomes that presently use comparable disposable microkeratome blades. The microkeratome blades are single-use disposable. The blades are packaged in a plastic clamshell case and the case is packaged in a tyvek pouch. The blades are provided sterile.
This document, K993122, is a 510(k) submission for disposable microkeratome blades. It focuses primarily on demonstrating substantial equivalence to existing, legally marketed devices rather than presenting a performance study with specific acceptance criteria and detailed study results for the device itself.
Therefore, many of the requested elements for a performance study are not explicitly present in the provided text. The submission relies on a descriptive comparison and design/function similarity to predicate devices.
Here's a breakdown of the information available and what is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Designed to be used in pre-existing, on the market, microkeratomes that presently use comparable disposable microkeratome blades. | "The Medical Sterile Products MSP M/K microkeratome blades are equivalent to those blades marketed by [predicate devices]... The blades are designed to be used in existing microkeratome machines: Chiron, Moria, Med-Logics, SCMD." |
| Material Equivalence: Steel used for the blade. | "The steel used for the blade in either configuration is the same..." (in comparison to different configurations of their own blade, also implying similarity to predicate device materials). "The blades are manufactured from surgical grade stainless steel." |
| Packaging Equivalence: Packaging method. | "...as well as the packaging..." (in comparison to different configurations of their own blade, also implying similarity to predicate device packaging). "The blades are packaged in a plastic clamshell case and the case is packaged in a tyvek pouch." |
| Sterilization Equivalence: Sterilization method. | "...and sterilization method." (in comparison to different configurations of their own blade, also implying similarity to predicate device sterilization). "The blades will be sterilized gamma radiation." "The blades are provided sterile." |
| Safety: No adverse safety indications when used as intended. | "When used according to the microkeratome manufacturers' instructions, there are no adverse safety indications for either of the blades." |
| Intended Use: Lamellar resection of the cornea. | "The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a performance study with a test set of samples. The determination of substantial equivalence is based on a descriptive comparison to predicate devices, not a new performance study on a specific number of blades.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No experts were used to establish ground truth for a test set, as no such test set or study is described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a surgical blade, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a physical surgical blade, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth was established for a performance study. The basis for approval is substantial equivalence to legally marketed predicate devices, which means their established safety and effectiveness serve as the "ground truth" for the new device's claim.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/ML device.
Summary of what the document does provide:
The document serves as a premarket notification (510(k)) to the FDA, asserting that the new disposable microkeratome blades are "substantially equivalent" to predicate devices already on the market. This type of submission relies on demonstrating that the new device has "the same intended use as the predicate device" and "the same technological characteristics as the predicate device," or "different technological characteristics than the predicate device" but that "the new device does not raise different questions of safety and effectiveness than the predicate device" and "the new device is as safe and effective as the predicate device."
In this case, the manufacturer primarily argues for same intended use (lamellar resection of the cornea using microkeratomes) and same technological characteristics (surgical grade stainless steel, similar design elements for compatibility with existing microkeratomes, similar packaging, and gamma radiation sterilization). The FDA's letter of "substantial equivalence" affirms this.
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510K Summary Medical Sterile Products Disposable Microkeratome Blades
Food and Drug Administration 510K Document Mail Center HFZ-401 Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850
FDA/CDRH/ODE/DMC
20 SEP 99 10 40
RECEIVED
sk-14
09/11/99
RE: 510K Submission - Microkeratome Blades from: Medical Sterile Products, Inc. Road 413 Km. 0.2 Rincon, Puerto Rico 00677
Submitter's Name: Gary C. Dionne
To: Document Control Clerk
Medical Sterile Products, Inc. is requesting 510k approval for its disposable microkeratome blades. The microkeratome blades are manufactured either with a prefixed plastic post or have a slot/holes in the blade. The plastic post fits into a slot within the microkeratome instrument and the slot/holes in the blade are used to affix the blades to a stainless steel post on the microkeratome. The steel used for the blade in either configuration is the same, as well as the packaging and sterilization method. The blades are designed to be used in pre-existing, on the market, microkeratomes that presently use comparable disposable microkeratome blades.
| Trade name : | MSP M/K BLADE |
|---|---|
| Common name: | microkeratome blade |
| Classification : | keratome, or/and blade, surgical saw, generaland plastic surgery |
| Establishment Registration Number : | 2618676 |
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Performance Standard:
The Medical Sterile Products disposable microkeratome blades are similar in design and function to those blades marketed by:
| Microspecialties, Inc.16 Higgins DriveMilford, CT 06460510k Number : K980510K980508 | (Releasable 510k details attached) |
|---|---|
| Howard Instruments, Inc.4749 Appletree LaneTuscaloosa, AL 35405510k Number : K972727 | (Releasable 510k details attached) |
Med-Logics, Inc. 9327 Blackley Street Temple City, CA 91780 510k Number : K962661 (Releasable 510k details attached)
Universal Refractive Instruments B. Graczyk, Inc. 61 Brookside Drive (Promotional information attached) Glendale, IL
Descriptive Comparison:
The Medical Sterile Products MSP M/K microkeratome blades are equivalent to those blades marketed by the above companies. The blades are designed to be used in existing microkeratome machines: Chiron, Moria, Med-Logics, SCMD.
Characteristics :
The microkeratome blades are single-use disposable. The blades are packaged in a plastic clamshell case and the case is packaged in a tyvek pouch. The blades are provided sterile.
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Certification of Safety and Effectiveness:
When used according to the microkeratome manufacturers' instructions, there are no adverse safety indications for either of the blades. The blades are manufactured from surgical grade stainless steel. The blades will be sterilized gamma radiation.
Labeling:
The pouch will indicate Medical Sterile Products name, address, product identification, lot number, sterilization notes, disposable, and federal law requirements. Other companies could have the products relabeled with their company name.
Sterilization:
Gamma Radiation
Isomedix, Inc. Division STERIS Contract Services Vega Alta, Puerto Rico 00692
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2000
Mr. Gary Dionne Director Medical Sterile Products, Inc. RD. 413, KM. 0.2 Rincon, PR 00677
Re: K993122 Trade Name: MSP M/K Blade Regulatory Class: I Product Code: 86 HNO Regulation: 886.4370 Dated: February 24, 2000 Received: February 24, 2000
Dear Mr. Dionne:
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 - Mr. Gary Dionne
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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Page of of
K993122 510(k) Number (if known):_
Device Name:__________________________________________________________
Indications For Use:
The MSP/MK Blade (#507-0028) is designed as a replacement blade for the Chiron Hansatome #507-0036-01 microkeratome for lamellar resection of the cornea.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ODE/DOD/DSDB Concurrence of CDRH, Office of Device Evaluation (ODE)
Dkauf
ivision Sign-Off) vision of Ophthalmic Devices 10(k) Number_k 993122
(Optional Format 3-10-98)
§ 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.