(251 days)
Not Found
No
The summary describes a wound dressing kit used with a wound vacuum system. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies.
Yes
The device is described as promoting wound healing by removing excess exudates, infectious materials, and tissue debris, which are therapeutic actions.
No
The device is a wound dressing kit used in conjunction with a wound vacuum system to promote wound healing by removing excess exudates, infectious materials, and tissue debris. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "single-use dressing" housed in a physical pouch, indicating it is a hardware medical device (a dressing kit) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dressing kit used in conjunction with a wound vacuum system to deliver negative pressure wound therapy. This therapy is applied externally to the wound.
- Device Description: The device is described as a single-use dressing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment. The device's function is purely mechanical (applying negative pressure) and physical (covering the wound).
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples. This device operates in vivo (on the body) to manage wounds.
N/A
Intended Use / Indications for Use
Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K09063) to deliver negative pressure wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious materials and tissue debris.
Spiral Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers
- Diabetic/Neuropathic Ulcers
- · Venous insufficiency Ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Skin flap and grafts
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
Gendayne Spiro Foam Dressing Kit is a single-use dressing is housed in a Tyvek/Mylar Peel Pouch.
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)
Non Clinical Tests: Biocompatibility tests were performed on the dressing kit in accordance to ISO 10993.
Report 13-02487-G1: the green foam dressing kit meets the requirements of the test as per ISO 10993-5, and is not considered to have a cytotoxic effect.
Report 13-02487-G2: the green foam dressing kit meets the requirements of the ISO 10993-10 guidelines. It did not show a significantly greater biological reaction than the sites injected with the control article.
Report 13-02487-G3: the green foam dressing kit displayed a Grade 1 sensitization rate and based on the scoring system of Kligman as per ISO 10993-10 guidelines, it is not considered significant and is classified as having a weak allergenic potential.
Report 13-02487-G4: the green foam dressing kit is considered non-pyrogenic and meets the requirements of the Pyrogen Test, as per ISO 10993-11 guidelines.
Report 13-02487-G5: the green foam kit did not induce a significantly greater biological reaction than the control extracts, when tested in Swiss Albino mice, therefore it is considered negative based on standards set by ISO 10993-11.
Sterilization validation was performed in accordance to ISO 11135. The sterilization activity confirms a 10^-6 sterility assurance level (SAL), by utilizing the half-cycle overkill approach which demonstrated total inactivation of a 10^-6 BI at half exposure time, on a four (4) pallet load of wound vacuum dressing sets.
Stability test was performed.
- Accelerated aging test
- Peel test
- Bubble test
- Ship test
- Package aerosol spore challenge test
All test results shows that the packages met the requirements of the protocol for 2 year equivalent aging. No significant degradation of seal was observed, bubble test showed no leaks at any test points, microbial challenge shows good resistance and no significant degradation, and bubble test after ship test showed no leaks.
Colorant test was performed on the blue and yellow colorant that makes the green foam.
Report 14-04232-N1: a test to determine the extractable amount of chemical compounds from sponsor test material was performed.
In the test against metals, no elements above reporting limit were detected in any of the colorants except for sodium in Reactint Blue X3LV. However, sodium was also observed in the control solution (purified water) this presence of sodium cannot be unequivocally attributed to blue colorant.
In the test against volatile organic compound (VOC), no VOC were observed in any of the colors nor samples.
In the SVOC analysis of the purified water extract, no SVOC attributable to the test article were observed. No SVOC were observed in colorant solutions.
In the target NVOC analysis of purified water extracts, no target-NVOC attributable to the test article were observed. No NVOC were observed in the colorant solutions.
In the Non-Target NVOC in purified water extracts, no additional peaks were observed in the LC chromatogram of samples compared to the LC chromatogram of control.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
A4-XLR8 Foam Dressing K092992
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Image /page/0/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 image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2015
Genadyne Biotechnologies Incorporated Mr. Chien-Ming Goh Vice President 16 Midland Avenue Hicksville, New York 11801
Re: K141961
Trade/Device Name: Spiro Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 23, 2015 Received: February 25, 2015
Dear Mr. Goh:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability 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
1
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141961
Device Name Spiro Foam Dressing Kit
Indications for Use (Describe)
Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K09063) to deliver negative pressure wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious materials and tissue debris.
Spiral Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers
- Diabetic/Neuropathic Ulcers
- · Venous insufficiency Ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Skin flap and grafts
| Type of Use (Select one or both, as applicable) | Transactional, Identified in a PPE Vehicle Category FilingOne-Time, Non-Transactional, PPE Vehicle Category Filing | Transactional, Identified in a PPE Vehicle Category Filing | One-Time, Non-Transactional, PPE Vehicle Category Filing | ||
|---|---|---|---|---|---|
| Transactional, Identified in a PPE Vehicle Category Filing | |||||
| One-Time, Non-Transactional, PPE Vehicle Category Filing |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
2014
Traditional 510k Summary
| General Information | Date: July 10, 2014 | ||
|---|---|---|---|
| 1. | Applicant | Genadyne Biotechnologies, Inc. | |
| 16 Midland Ave, | |||
| Hicksville, NY 11801 | |||
| (t) 516.487.8787 | |||
| (f) 516.977-8974 | |||
| 2. | Contact Person | Mr. Chien-Ming GOH (Andrew) | |
| Vice President | |||
| Genadyne Biotechnologies Inc. | |||
| 16 Midland Ave, | |||
| Hicksville, NY 11801 | |||
| (t) 516.217.0101 | |||
| (f) 516.977.8974 | |||
| 3. | Trade Name | Genadyne Spiro Foam Dressing Kit | |
| (Ref: XF-SPMK1) | |||
| 4. | Common Name | Foam Dressing | |
| 5. | Classification Name | Powered Suction Pump | |
| 6. | Regulation Number | 21 CFR 878.4780 | |
| 7. | Product Code | OMP | |
| 8. | Class in which Device has | ||
| been placed | Class II | ||
| 9. | Panel | General & Plastic Surgery | |
| 10. | Reason for Premarket | ||
| Notification | New Device | ||
| 11. | Identification of Legally | ||
| Marketed Device Which We | |||
| Can Claim Substantial | |||
| Equivalence (Predicate | |||
| Device) | A4-XLR8 Foam Dressing K092992 | ||
| 12. | Brief Description of Device | Gendayne Spiro Foam Dressing Kit is a single-use | |
| dressing is housed in a Tyvek/Mylar Peel Pouch. |
4
13. Indications for use [21 CFR 807.92(a)(5)]
Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious materials and tissue debris.
Spiro Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers .
- Diabetic/Neuropathic Ulcers .
- Venous insufficiency Ulcers ●
- Traumatic wounds ●
- Post-operative and dehisced surgical . wounds
- Skin flap and grafts .
| No. | Foam | Port Tubing | Film | |
|---|---|---|---|---|
| 1. | Materials | |||
| Used: | Flexible Polyether | |||
| and Polyester | ||||
| Polyurethane Foam | Silicone | Polyurethane | ||
| 2. | Size: | 104 +/- 1.5 cm | ||
| uncoiled length x 1.9 | ||||
| +/- .3 cm width x | ||||
| 1.6 +/-0.15 cm height | 31 inches | 26 x 30 cm |
14. Technological Characteristics
Table of Comparison to Predicate Devices:
| Predicate | New | |
|---|---|---|
| Parameters | Genadyne | |
| A4-XLR8 Foam Dressing | Genadyne | |
| Spiro Foam Dressing Kit | ||
| 510(k) Number | K092992 | |
| Indications for Use | Genadyne A4-XLR8 Foam Dressing | |
| Kits are intended to be used in | ||
| conjunction with the Genadyne Wound | ||
| Vacuum System to deliver negative | ||
| pressure to the wound. Genadyne | ||
| Wound Vacuum System is indicated for | ||
| patients who would benefit from a | ||
| suction device particularly as the device | ||
| may promote wound healing by the | Genadyne Spiro Foam Dressing Kit is | |
| intended to be used in conjunction with | ||
| the Genadyne A4-XLR8 Wound | ||
| Vacuum System (K090638) to deliver | ||
| negative pressure wound therapy to the | ||
| wound. Genadyne A4-XLR8 Wound | ||
| Vacuum System is indicated for patients | ||
| who would benefit from a suction | ||
| device, particularly as the device may |
5
| | removal of excess exudates, infectious
materials and tissue debris. | promote wound healing by the removal
of excess exudates, infectious materials
and tissue debris. |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | A4-XLR8 Foam Dressing is appropriate
for use on the following wounds:
• Pressure ulcers
• Diabetic/Neuropathic Ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Post-operative and dehisced
surgical wounds
• Skin flap and grafts | A4-XLR8 Foam Dressing is appropriate
for use on the following wounds:
• Pressure ulcers
• Diabetic/Neuropathic Ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Post-operative and dehisced
surgical wounds
Skin flap and grafts |
| Foam Dressing
Material | Flexible Polyether and Polyester
Polyurethane Foam | Flexible Polyether and Polyester
Polyurethane Foam |
| Hydrophobic | Yes | Yes |
| Sizes: | 7.5 cm X 10 cm x 3.3cm
12.5 cm x 18 cm x 3.3 cm
15 cm x 26 cm x 3.3 cm | 104 +/- 1.5 cm uncoiled length x 1.9 +/-
.3 cm width x
1.6 +/-0.15 cm height |
| For use with Negative
Pressure Wound
Therapy Systems | Yes | Yes |
| Sterile | Yes | Yes |
| Kit Content | Silicone Tubing
Transparent Adhesive Film | Silicone Tubing
Transparent Adhesive Film |
Non Clinical Tests 15.
| XLR8 Spiro Dressing Kit | Biocompatibility tests were performed on the dressing kit in accordance to ISO 10993.
Report can be found in 013_Attachment_D in the RTA submission. | In Report 13-02487-G1, the green foam dressing kit meets the requirements of the test as per ISO 10993-5, and is not considered to have a cytotoxic effect.
In Report 13-02487-G2, the green foam dressing kit meets the requirements of the ISO 10993-10 guidelines. It did not show a significantly greater biological reaction than the sites injected with the control article.
In Report 13-02487-G3, the green foam dressing kit displayed a Grade 1 sensitization rate and based on the scoring system of Kligman as per ISO 10993-10 guidelines, it is not considered significant and is classified as having a weak allergenic potential.
In Report 13-02487-G4, the green foam dressing kit is considered non-pyrogenic and meets the requirements of the Pyrogen Test, as per ISO 10993-11 guidelines.
In Report 13-02487-G5, the green foam kit did not induce a significantly greater biological reaction than the control extracts, when tested in Swiss Albino mice, therefore it is considered negative based on standards set by ISO 10993-11. |
| ------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
6
| Sterilization validation
was performed in
accordance to ISO
11135.
Report can be found in
016_Attachment I in the
original submission. | The sterilization activity confirms a $10^{-6}$ sterility
assurance level (SAL), by utilizing the half-cycle
overkill approach which demonstrated total inactivation
of a $10^{-6}$ BI at half exposure time, on a four (4) pallet
load of wound vacuum dressing sets. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability test was
performed and the report
can be found in
015_Attachment H in the
original submission. | In the stability test, we performed:-
- Accelerated aging test
- Peel test
- Bubble test
- Ship test
- Package aerosol spore challenge test
All test results shows that the packages met the
requirements of the protocol for 2 year equivalent
aging. No significant degradation of seal was
observed, bubble test showed no leaks at any test
points, microbial challenge shows good resistance and
no significant degradation, and bubble test after ship
test showed no leaks. |
| Colorant test was
performed on the blue
and yellow colorant that
makes the green foam.
The report can be found
in 015_Attachment F. | In Report 14-04232-N1, a test to determine the
extractable amount of chemical compounds from
sponsor test material was performed.
In the test against metals, no elements above reporting
limit were detected in any of the colorants except for
sodium in Reactint Blue X3LV. However, sodium was
also observed in the control solution (purified water)
this presence of sodium cannot be unequivocally
attributed to blue colorant.
In the test against volatile organic compound (VOC),
no VOC were observed in any of the colors nor
samples.
In the SVOC analysis of the purified water extract, no
SVOC attributable to the test article were observed. No
SVOC were observed in colorant solutions.
In the target NVOC analysis of purified water extracts,
no target-NVOC attributable to the test article were
observed. No NVOC were observed in the colorant
solutions.
In the Non-Target NVOC in purified water extracts, no
additional peaks were observed in the LC
chromatogram of samples compared to the LC
chromatogram of control. |
- Conclusion & Based on the information presented above, it is 16. Determination of concluded that the Spiro Foam Dressing Kit is Substantial Equivalence substantially equivalent to the predicate device.