(73 days)
Not Found
No
The device description and intended use clearly state that the device is a simple absorbent sponge made from formalized PVA. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The devices are described as sponges used to absorb fluids during ophthalmic surgery, indicating they are surgical tools for fluid management rather than devices intended to treat or prevent a disease or condition.
No
The device is described as an absorbent sponge used to soak up fluids during ophthalmic surgery, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly states the device is a "sterile, dried and compressed sponge" made from "formalized PVA sponge," indicating it is a physical, hardware-based medical device used for fluid absorption.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb fluids from the operative field in ophthalmic surgery." This is a physical function performed during a surgical procedure on a patient's body.
- Device Description: The device is described as a sponge used for fluid absorption. This aligns with a surgical tool, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.
Product codes
86 HOZ
Device Description
The Eye Drain 80cc, Bye Drain 400cc, Bye Wick 8-inch, and Surgical Spears are packaged individually as a sterile, dried and compressed sponge. They are used to absorb fluids from the operative field in ophthalmic surgery. M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are made from formalized PVA sponge, which is a condensation product of polyviny! alcohol and formaldehyde. Once the chemical reaction has taken place and the foam in the formalin and alcohol and formaldehyde. Once the chemical reaction has taken place and the foam in the formalia is produced, the foam is washed and cleaned of any residual chemicals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Although this is a new product for M-PACT, it is a product which is substantially equivalent to Eye Drain 800cc, Eye Drain 400cc, Eye Wick Sunch, were on the market p equivalent to Eye Drain 80cc, bye United Commerce and which were on the market prior that are currently marketed in interstate commerce and when of 1976 (May 28, 1976).
to the date of the enactment of the Medical Device Amendrom of 1976 (May 28, 1976).
Commen to the data of the enactment of the Medical Device Alichesters or 11, 2017
The M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-Inch, and Surgical Spears The M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Pristiended use as the Merocel I Bye
are identical in size, shape, material composition and intended use as the Merocel Bye are identical in size, shape, material composition and Surgical Spears currently marketed
Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears currently, Florida Drain 80cc, Eye Drain 400cc, Lye Wick o-nitity (Komed, Jicks opville, Florida). Since the
by Merocel Corporation, Mystic, Connecticut (Komed, Jacksonville, Florida). Since by Merocel Corporation, Mystic, Comecucar (Nick 8-inch, and Surgical Spears are
M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are M-PACT Bye Drain 80cc, Lye Drain 400cc, Eye WiEk of Internal I
identical to product currently marketed by Merocel, the only changes will be in regard to labeling and packaging.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K97/832
SUMMARY STATEMENT
Barry Hale M-PACT Corporation 1040 OCL Parkway Eudora, KS 66025 913-542-2135 Contact Barry Hale May 14, 1997
Name of Product: Sponge, Opthalmic
M-PACT Corporation, registration number 1928508, wishes to file an intent to market
And Surgination Design 90cc, Eve Drain 400cc, Eve Wick 8-inch, and Surgico M-PACT Corporation, registration number 1928-06, Wiskes With & Margical
sterile, single-use Eye Drain 80cc, Eye Drain 400cc, Eye Wick Birghcal
Sterile, single-use for a forma sterle, single-use Eye Drain 80cc, Eye Drain 400cc, Eye Wick Sheet, Will market the Spears muractured from formalized PVA sponge material. The classification name for the devices
products under the trade name of TVALON®. The classification name for the de products under ale aic aic air and CFR 886.4790).
The Eye Drain 80cc, Bye Drain 400cc, Bye Wick 8-inch, and Surgical Spears are The Eye Drain 80cc, Eye Drain 400cc, Eye Wilks Punch, and compressed sponge. They are used to
packaged individually as a sterile, dried and compressed sponge. They are used t packaged individually as a sterne, drive the start of a progety.
M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are M-PACT Eye Drain 80cc, Eye Drain 400cc, Lye W.R. 9 min and of polyviny!
made from formalized PVA sponge, which is a condensation product of polyviny! made from formalized TVA sponge, which is a condensands promote on the foam
alcohol and formaldehyde. Once the chemical reaction has taken place and the foam
in the formalia alcohol and formaldehyde. Once the cheined clean of any residual chemicals.
M-PACT Corporation is the manufacturer of the formalized PVA sponge. M-PACT has
s of the bearly BAX Compresson (Departs, Colorado) to complete the packaging M-PACT Corporation is the manufacturer on the formation and the packaging
contracted with IPAX Corporation (Denver, Colorado) to complete the packaging contracted with IPAA Corporation (Denver) 300 and 100 sterilization services.
Although this is a new product for M-PACT, it is a product which is substantially Although this is a new product for M-PAC. It is a production in Surgical Spears.
equivalent to Eye Drain 800cc, Eye Drain 400cc, Eye Wick Sunch, were on the market p equivalent to Eye Drain 80cc, bye United Commerce and which were on the market prior that are currently marketed in interstate commerce and when of 1976 (May 28, 1976).
to the date of the enactment of the Medical Device Amendrom of 1976 (May 28, 1976).
Commen to the data of the enactment of the Medical Device Alichesters or 11, 2017
The M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-Inch, and Surgical Spears The M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Pristiended use as the Merocel I Bye
are identical in size, shape, material composition and intended use as the Merocel Bye are identical in size, shape, material composition and Surgical Spears currently marketed
Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears currently, Florida Drain 80cc, Eye Drain 400cc, Lye Wick o-nitity (Komed, Jicks opville, Florida). Since the
by Merocel Corporation, Mystic, Connecticut (Komed, Jacksonville, Florida). Since by Merocel Corporation, Mystic, Comecucar (Nick 8-inch, and Surgical Spears are
M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are M-PACT Bye Drain 80cc, Lye Drain 400cc, Eye WiEk of Internal I
identical to product currently marketed by Merocel, the only changes will be in regard to labeling and packaging.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular and contains the department's name around the perimeter. In the center is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 | 1997
Mr. Barry Hale M-PACT Corp. 1040 OCL Parkway Fudora, KS 66025
Re: K971832
K971832
Trade Name: Ivalon PVA Surgical Spear; Ivalon Eye Drain, 80cc; Ivalon Eye Drain,
Trade Name: Ivalon PVA Surgical Spear; Ival 400cc; Ivalon Eye Wick
Regulatory Class: II Product Code: 86 HOZ Dated: May 14, 1997 Received: May 19, 1997
Dear Mr. Hale:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(ts) nothleakter tially equivalent (for the indications for above and we have determined the devices marketed in interstate commerce prior to May 28, 1976, use stated in the enclosure) to device Amendments, or to devices that have been
the enactment date of the Medical Device Amendarel Food. Drug, and Cosme the enactment date of the Medical Device rine Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal controls provisions of reclassified in accordance with the provisions or the general controls provisions of the (Act). You may, therefore, market the device, successes and groundents for annual registration,
Act. The general controls provisions of the Act include requirements mishrandi Act. The general controls provisions of the Actual requence requence in the randing and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n and the many and If your device is classified (see above) into exist additional controls. Existing major (Premarket Approval), it may be subject to sam ations of Federal Regulations, Title 21,
regulations affecting your device can be found in the Code of Federaliance with the regulations aftecting your device can be round as an assumes compliance with the Parts 800 to 895. A substantally couragents, as set forch in the Quality System
current Good Manufacturing Practice requirements, as set forch in the Right current Good Manufacturing Practice (General regulation (21 CFR Part 820) and than, through
Regulation (QS) for Medical Devices: (GDA) will verify such icegulation (QS) inspections, the Food Indian may result in regulation may result in regilatory ac periodic (QS) inspections, the Food and Drag Pressult in regulation may result in regulatory action. In
assumptions. Failure to comply with the GMP regulation may result an assumptions. Fallure to comply with the GMT regorifican whice in the Eederal addition, FDA may publish lurinel amour. Remarket notification submission does not affect
Register. Please note: this response to your premarket nonification submicres under Register. Please note: This response to your press. It through 542 of the Act for devices under any obligation you might have under sections or other Federal laws or regulations.
the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Barry Hale
This letter will allow you to begin marketing your device as described in your 510(k)
Dremarket notification . The EDA findi 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 slevice to proceed to the marker. " --
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. Raeyl lorenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
INDICATIONS FOX USE:
The Ivalon® Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are =================================================================================== The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Opens, 2007, 2007, 1
used to absorb fluids from the operative field in ophthalmic surgery.
(Please do not write below this line - use another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| my-chen Shir of (Division Sign-Off) Division of Ophthalmic Devices | |
|---|---|
| 510(k) Number | K971832 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |