(286 days)
No
The device description and intended use clearly indicate that these are physical sponges and shields for fluid management and light shielding during ophthalmic surgery. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is used for tissue manipulation, fluid management, and light shielding during ophthalmic procedures, all of which are surgical aids rather than direct therapeutic actions.
No
The device description and intended use clearly state that these devices are designed for tissue manipulation, fluid management, and shielding during ophthalmic surgical procedures, not for diagnostic purposes.
No
The device description clearly outlines physical components made of Polyvinyl Alcohol (PVA) or Cellulose sponge and polypropylene handles, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these devices are used for:
- Tissue manipulation
- Management of fluids in the operative field
- Shielding the retina from light
- Moistening the cornea
These functions are all related to surgical procedures performed directly on the eye, not on samples taken from the body for laboratory analysis.
Therefore, the Network Eye Spears, Points, Wicks, Drains, and Shields are surgical instruments/accessories used during ophthalmic surgery, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field.
Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field.
Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.
Product codes
HOZ
Device Description
Network Eve Spears, Points, Drains, Wicks and Shields are single devices designed for tissue manipulation, fluid management and shielding of light in ophthalmic surgery. Spears and points consist of a triangle of dry Polyvinyl Alcohol (formalized) Sponge (PVA) or Cellulose sponge, either attached to a polypropylene handle for handling or separate to be picked up by forceps. The triangular shape allows the surgeon to carry out pinpoint absorption of liguid. Drains and Wicks are PVA Sponges in various sizes and shapes for wicking of fluid away from the operative field. Shields are circular-shaped PVA Sponges that moisten the cornea and reduce the light intensity on the retina during surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea, eye surface
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)
Non-clinical testing for biocompatibility, sterility, and product/package stability was submitted to demonstrate substantial equivalence to the predicate devices. No clinical tests were submitted.
1. Biocompatibility
PVA:
Biocompatibility tests recommended in ISO 10993 with the additional tests recommended in Blue Book Memo, G95-1, for evaluation of devices in contact with mucosal membranes or breached or compromised surfaces for a limited duration, were submitted for PVA Sponge and results found to be acceptable; Cytoloxicity, Sensitization, Primary Skin Irritation, Acute Systemic Toxicity, Limulus Amebocyte Lysate (LAL, Gel Clot Method) testing to measure post-sterilization endotoxin demonstrates that NMP PVA Sponge devices are below the maximum specification limit of 20 EU/device. These biocompatibility tests demonstrate that NMP Polyvinyl Alcohol (formalized) Sponge devices are as safe as the predicate devices in that they are biocompatible for the intended use (as are the predicate devices).
Cellulose:
Biocompatibility tests submitted for NMP Cellulose Sponge devices, together with the long history of safe clinical use of cellulose sponge, support the conclusion that NMP Cellulose Sponge devices do not produce adverse local or systemic effects when in limited duration contact with mucosal membranes or breached or compromised surfaces: Cytoloxicity, Sensitization. Limulus AmeBocyte Lysate (LAL, Gel Clot Method) testing to measure post-sterilization endotoxin demonstrates that NMP Cellulose Sponge devices are below the maximum specification limit of 20 EU/device. These biocompatibility tests demonstrate that NMP Cellulose Sponge devices are as safe as the predicate devices in that they are biocompatible for the intended use (as are the predicates).
2. Sterility
Network ophthalmic sponge products will be sterlized with electron beam radiation to an SAL of 10". In accordance with the requirements of ISO 11137-1:2006 and ISO 11137-2:2012, a Method 1 sterilization validation supports the SAL of 10°. These submitted results demonstrate that NMP Ophthalmic Sponge devices are as safe as the predicate devices in that they are sterlized by the same method (radiation) and to the same sterility assurance (10) as predicate devices K920354, K923922 and K990671; and in the case of predicates K920354 & the same radiation source (electron beam).
3. Product/Package Stability (Shelf Life)
Package integrity and product functionality testing performed on accelerated-aged product; manufactured, packaged and sterilized under normal production conditions: demonstrates that NMP Ophthalmic Sponge devices are functional for the defined shelf life of the product packaging provides a sterile barrier for the defined shelf life of the product. The shelf life testing submitted demonstrates that NMP Ophthalmic Sponge devices are as effective and perform as well as the predicate devices in that they are maintained as functional and in sterile condition by the sterile barrier packaging (as are the predicates).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K920354, K923922, K972693, K990671
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
510(k) Summary:
Owner:
Network Medical Products, Ltd. Coronet House, Kearsley Road Ripon, North Yorkshire HG4 2SG, UK
Phone: (44) 01765 609555
Submission contact: Alison March Senior QA/RA Manager Alison.M@networkmedical.co.uk (44) 01765 609555
OCT 2 9 2013
Date prepared: October 27, 2013
Device Common Name: Ophthalmic Sponge
Device Proprietary Name: Network Eye Spears, Points, Wicks and Shields
Classification: Class II
Regulation Number: 886.4790
Product Code: HOZ
Predicate Devices:
Ultracell Medical Technologies, Inc., Ophthalmic Sponges, K920354 Ultracell Medical Technologies, Inc., Surgical Spears, K923922 DeRoyal Industries, Inc., Surgical Eye Spears, K972693 Hurricane Medical, Inc., Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, K990671
Indication for Use:
Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field.
Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field.
Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.
Description:
Network Eve Spears, Points, Drains, Wicks and Shields are single devices designed for tissue manipulation, fluid management and shielding of light in ophthalmic surgery. Spears and points consist of a triangle of dry Polyvinyl Alcohol (formalized) Sponge (PVA) or Cellulose sponge, either attached to a polypropylene handle for handling or separate to be picked up by forceps. The triangular shape allows the surgeon to carry out pinpoint absorption of liguid. Drains and Wicks are PVA Sponges in various sizes and shapes for wicking of fluid away from the operative field. Shields are circular-shaped PVA Sponges that moisten the cornea and reduce the light intensity on the retina during surgery.
Comparison to Predicate Devices:
Network Eye Spears, Points, Drains, Wicks and Shields are equivalent to the predicates in intended use, design, and component materials as tabulated below.
1
Comparison to Predicates:
-- '--
| Characteristics | Network Eye Spears,
Points, Wicks, Drains
and Shields
K130117 | Ultracell Eye
Spears, Points,
Wicks, Drains and
Shields
K920354 &K923922 | DeRoyal Surgical
Eye Spear
K972693 | Hurricane Medical
Surgical Spears and
Sponges, Corneal
Light Shield,
Drainage Wick
K990671 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Eye Spears and Points:
Indicated for all
microsurgical
ophthalmic procedures
for tissue manipulation
and management of
fluids in the operative
field.
Wicks and Drains:
Indicated for all
microsurgical
ophthalmic procedures
for management of
fluids in the operative
field.
Shields: Indicated for
placement on the
cornea to moisten the
cornea and shield the
retina from intense
operating light during
ophthalmic surgery. | Fluid control and
tissue manipulation of
the surface of the eye
during eye surgery. | Used to absorb
fluids from the
operative field
during ophthalmic
and microscopic
surgical procedures. | Used to remove
excess fluid and
debris from the
surgical area or
instrument. Also,
placed on the cornea
to moisten the cornea
and protect the retina
from the intense
operating light during
ophthalmic surgery. |
| Biocompatibility | Acceptable results
according to FDA Blue
Book Memo, G95-1, on
use of ISO 10993-1
tests. | Acceptable results
according to FDA
Blue Book Memo,
G95-1, on use of ISO
10993-1 tests. | Acceptable results
according to FDA
Blue Book Memo,
G95-1, on use of
ISO 10993-1 tests. | Unknown |
| Principles of
operation | Dry sponge wicking
action removes fluid;
triangular shape option
allows for targeted
absorption where
needed; sponge shield
is physical barrier for
reduction of light. | Dry sponge wicking
action removes fluid;
triangular shape
option allows for
targeted absorption
where needed;
sponge shield is
physical barrier for
reduction of light. | Dry sponge wicking
action removes
fluid; triangular
shape option allows
for targeted
absorption where
needed. | Dry sponge wicking
action removes fluid;
triangular shape
option allows for
targeted absorption
where needed;
sponge shield is
physical barrier for
reduction of light. |
| Sponge material | Polyvinyl Alcohol
(formalized) Sponge
and Cellulose Sponges | Polyvinyl Alcohol
(formalized) Sponge
and Cellulose
Sponges | Cellulose Sponge | Hydrocellulose, PVA
Sponge, viscose and
US-origin cotton |
| Handle material,
spears | Polypropylene | Polypropylene | High density plastic | Plastic |
| Sterility | E-Beam Radiation,
SAL 106; Sterile Barrier
Packaging | E-beam Radiation,
SAL 106; Sterile
Barrier Packaging | Eto, SAL 106;
Sterile Barrier
Packaging | Gamma Radiation,
SAL 106; Sterile
Barrier Packaging |
Non-clinical Testing:
Non-clinical testing for biocompatibility, sterility, and product/package stability was submitted to demonstrate substantial equivalence to the predicate devices, as detailed below. No clinical tests were submitted.
2
1. Biocompatibility
PVA:
Biocompatibility tests recommended in ISO 10993 with the additional tests recommended in Blue Book Memo, G95-1, for evaluation of devices in contact with mucosal membranes or breached or compromised surfaces for a limited duration, were submitted for PVA Sponge and results found to be acceptable; Cytoloxicity, Sensitization, Primary Skin Irritation, Acute Systemic Toxicity, Limulus Amebocyte Lysate (LAL, Gel Clot Method) testing to measure post-sterilization endotoxin demonstrates that NMP PVA Sponge devices are below the maximum specification limit of 20 EU/device. These biocompatibility tests demonstrate that NMP Polyvinyl Alcohol (formalized) Sponge devices are as safe as the predicate devices in that they are biocompatible for the intended use (as are the predicate devices).
Cellulose:
Biocompatibility tests submitted for NMP Cellulose Sponge devices, together with the long history of safe clinical use of cellulose sponge, support the conclusion that NMP Cellulose Sponge devices do not produce adverse local or systemic effects when in limited duration contact with mucosal membranes or breached or compromised surfaces: Cytoloxicity, Sensitization. Limulus Amebocyte Lysate (LAL, Gel Clot Method) testing to measure post-sterilization endotoxin demonstrates that NMP Cellulose Sponge devices are below the maximum specification limit of 20 EU/device. These biocompatibility tests demonstrate that NMP Cellulose Sponge devices are as safe as the predicate devices in that they are biocompatible for the intended use (as are the predicates).
2. Sterility
Network ophthalmic sponge products will be sterlized with electron beam radiation to an SAL of 10". In accordance with the requirements of ISO 11137-1:2006 and ISO 11137-2:2012, a Method 1 sterilization validation supports the SAL of 10°. These submitted results demonstrate that NMP Ophthalmic Sponge devices are as safe as the predicate devices in that they are sterlized by the same method (radiation) and to the same sterility assurance (10) as predicate devices K920354, K923922 and K990671; and in the case of predicates K920354 & the same radiation source (electron beam).
3. Product/Package Stability (Shelf Life)
Package integrity and product functionality testing performed on accelerated-aged product; manufactured, packaged and sterilized under normal production conditions: demonstrates that NMP Ophthalmic Sponge devices are functional for the defined shelf life of the product packaging provides a sterile barrier for the defined shelf life of the product. The shelf life testing submitted demonstrates that NMP Ophthalmic Sponge devices are as effective and perform as well as the predicate devices in that they are maintained as functional and in sterile condition by the sterile barrier packaging (as are the predicates).
Conclusion:
Network Eye Spears, Points, Wicks and Shields are equivalent to the predicates in intended use, design, and component materials, and are identical in raw material and components to predicate devices K920354 &K923922. Non-clinical testing demonstrates that manufacturing processes undertaken by NMP produce substantially equivalent devices that are as safe, as effective, and perform as well as the predicates as follows:
- Biocompatibility tests demonstrate that NMP Ophthalmic Sponge devices are as . safe as the predicate devices in that they are biocompatible for the intended use (as are the predicates).
- . NMP Ophthalmic Sponge devices are as safe as the predicate devices in that they are sterilized by the same method (radiation) and to the same sterility assurance (108) as predicate devices K920354, K923922 and K990671; and in the case of predicates K920354 &K923922, by the same radiation source (electron beam).
- . Shelf life testing submitted demonstrates NMP Ophthalmic Sponge devices are as effective and perform as well as the predicate devices in that they are maintained as functional and sterile by the sterile barrier packaging (as are the predicates).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
October 29, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Network Medical Products, Ltd % Ms. Alison March Senior QA/RA Manager Coronet House, Kearslev Road Ripon, North Yorkshire HG4 2SG, United Kingdom
Re: K130117
Trade/Device Name: Network Eye Spears. Points. Drains, Wicks and Shield Regulation Number: 21 CFR 886.4790 Regulation Name: Sponge, Ophthalmic Regulatory Class: Class II Product Code: HOZ Dated: September 17, 2013 Received: September 17, 2013
Dear Ms. March:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract. Iiability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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 equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Alison March
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -S
· for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K130117
Device Name: Network Eye Spears, Points, Wicks, Drains and Shields
Indications for Use:
Network Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field.
Network Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field.
Network Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.
Prescription Use X (part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
)ア
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) :
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leonid.Livshitz
S
2013:10.23
'00'04-14:24:33
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K130117
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