(76 days)
For infusion of fluid and air during vitrectomy.
During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.
Here's an analysis of the provided text regarding acceptance criteria and study information for the American Medical Devices, Inc. Moistair™ Fluid/Air Tubing Set:
It's important to note that this 510(k) summary (K974561) is for a Class II medical device and focuses primarily on establishing substantial equivalence to a predicate device. Substantial equivalence typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed predicate device. This often means testing to ensure it meets performance requirements similar to or demonstrably equivalent to its predicate, rather than establishing entirely new performance criteria through extensive clinical trials.
The provided document does not contain detailed acceptance criteria tables with specific quantitative metrics or a full study report in the way one might expect for a complex, novel device or a clinical outcome study. Instead, it describes compliance with established standards and performance characteristics in comparison to a predicate.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, a formal table of quantitative acceptance criteria is not present. However, we can infer performance characteristics the device meets. The device relies on existing standards for sterilization and pyrogenicity.
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | For infusion of fluid and air during vitrectomy. | Device is designed for and stated to be for infusion of fluid and air during vitrectomy, demonstrating substantial equivalence to the predicate device in this regard. |
| Packaging | Tyvek to Poly packaging for sterility and product integrity. | "Tyvek to Poly" packaging is used, matching the predicate device. Specific performance criteria (e.g., seal strength, shelf life) are not detailed but are implied by the use of this standard material and validated ETO sterilization. |
| Materials | PVC Tubing Line, .22 micron Filter, Stopcock, IV Spike, Plastic Drip Chamber, Plastic Humidifying Filter. | The device uses these materials, matching the predicate. Implied acceptance criteria relate to biocompatibility (implicitly covered by material selection and and substantial equivalence to a legally marketed device) and functional integrity during use. |
| Sterilization ETO | Device must be sterile, achieving a Sterility Assurance Level (SAL) of 10^-6. Ethylene Oxide (ETO) residues within limits. | Sterilized by ETO. SAL is 10^-6. Ethylene oxide residue limits: 25 ppm (ethylene oxide), 25 ppm (ethylene chlorohydrin), 250 ppm (ethylene glycol). This meets established standards for ETO sterilization. |
| Non-pyrogenic | Device must be non-pyrogenic. | LAL Method used to determine that each lot is non-pyrogenic. Manufacturing environment is controlled to lessen the likelihood of pyrogen-causing bacteria. This meets established standards for non-pyrogenicity. |
| Humidifying Filter | (Implicit) Humidifies dry air prior to introduction into the eye. Requires 1 cc BSS injection into port. | The device incorporates a humidifying filter designed for this purpose. Performance specification (e.g., minimum humidification level, flow rate impact) are not specified here, but its function is described. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe "test sets" in the context of clinical or performance data for specific device outcomes beyond sterility and pyrogenicity.
- Sterility and Pyrogenicity Validation: These are typically performed on a statistically significant sample size from manufacturing lots according to AAMI and LAL method guidelines, respectively. The specific sample sizes for these validations are not mentioned in this summary.
- Data Provenance: The document does not describe patient data or clinical trial data collection. The information presented is related to manufacturing validation and device characteristics, not clinical performance. Thus, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable to the information provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided in the context of this 510(k) submission. "Ground truth" in this document refers to established standards and methods for sterilization and pyrogenicity, which are determined by regulatory bodies and scientific consensus, not individual experts for a specific test set.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or expert reviews of ambiguous cases. Here, compliance is determined by validated laboratory methods (AAMI Overkill, LAL Method) against established regulatory limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and would evaluate the impact of an AI algorithm on reader performance. The Moistair™ Fluid/Air Tubing Set is a therapeutic/surgical device, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone AI algorithm performance study was not done or described. This device is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance claims is primarily based on:
- Established scientific and regulatory standards: Such as AAMI guidelines for ETO sterilization and the LAL Method for pyrogenicity.
- Engineering and design specifications: Demonstrating that the device's materials and construction are substantially equivalent to a legally marketed predicate device.
- Predicate device's known safety and effectiveness: The Moistair™ Tubing Set establishes substantial equivalence to the Grieshaber & Co. device, implying that the predicate's extensive history and regulatory clearance serve as a "ground truth" for acceptable performance for this device type.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm.
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P.02
K974561
Image /page/0/Picture/2 description: The image shows a logo with the letter "A" in a white square on the left. To the right of the square is a black rectangle with several vertical white lines. To the right of the black rectangle is the text "AMERICAN MEDICAL DEVICES, Inc." The text is stacked vertically, with "AMERICAN" on top, followed by "MEDICAL", and then "DEVICES, Inc."
FEB 1 9 1998
1100 Northside Drive Atlanta, Georgia 30318
(Revised) February 12, 1998
Premarket Notification [510(k)] Summary
Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 303 18 Phone: (404) 815-5233 (404) 815-5235 Fax:
Official Correspondent: Frank J. Tighe
Trade Name: The American Medical Devices, Inc., Moistair™ Pluid/Air Tubing Set.
Common Name: Fluid/Air Tubing Set
Registration Number: We have registered but have not received our application back as of this date.
Class: Class II
Class Name/Number: 880.5725
Panel: Ophthalmic
Product Code: FRN
Device Description: During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.
Page 1 Summ
| Toll-Free | Direct | Facsimile | Internet |
|---|---|---|---|
| 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com |
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Statement of indications for use. - For infusion of fluid and air during vitrectomy
Substantial Equivalence Comparison
| American MedicalDevices, Inc. | Grieshaber & Co. | |
|---|---|---|
| PackagingTyvek to Poly | X | X |
| For infusion of fluid andAir during vitrectomy | X | X |
| Materials: PVC Tubing Line, .22 micronFilter, Stopcock, IV Spike | X | X |
| Sterilization ETO | X | X |
| Humidifying Filter | X | X |
Sterility
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method
Packaging Material: Tyvek Pouch with a Ploymylar Sheath.
The SAL is 10 to the -6.
The maximum levels of residues of ethylene oxide: 25 parts per million; ethylene chlorohydrin: 25 parts per million and ethylene glycol: 250 parts per million.
This device is non-pyrogenic and the LAL Method is used to make that determination.
Pyrogens: We control the manufacturing environment to lessen the likelihood of pyrogen causing bacteria. In addition the LAL Method is used to determine that each lot is non-pyrogenic.
Materials Use In Manufacture: PVC Tubing, .22 Micron Millipore Filter, PVC 3way stopcock, Plastic Drip Chamber, Plastic Humidifying Filter.
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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
FEB 1 9 1998
Mr. Frank J. Tighe Offical Correspondent American Medical Devices, Inc. 1100 Northside Drive Atlanta, GA 30318
Re: K974561 Trade Name: Moistair ™ Fluid Air Tubing Set Regulatory Class: II Product Code: 80 FRN Dated: December 3, 1997 Received: December 5, 1997
Dear Mr. Tighe:
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. Frank J. Tighe
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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 Ralph 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_1_of_1
51D(k) Number (if known): __ K974561
Moistair Fluid Air Tubing Set Device Name:_
Indications For Use:
For infusion of fluid and air during vitrectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) |
Division of Ophthalmic Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use_ (Per 21 CFR 801.109)
: 上
. . . . .
(
OR
Over-The-Counter Use____
(Optional Format 1-2-16)
§ 886.4360 Ocular surgery irrigation device.
(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general 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.