(161 days)
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Not Found
No
The 510(k) summary describes a surgeon's glove and its testing for chemotherapy drug resistance. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies and metrics relate to material properties and chemical resistance, not algorithmic performance.
No
The device, a surgeon's glove, is intended to protect a surgical wound from contamination, which is a preventative measure, not a therapeutic treatment for a disease or condition.
No
The device is a surgeon's glove intended to protect a surgical wound from contamination, which is a protective function, not a diagnostic one.
No
The device is a physical surgeon's glove made of Flexylon, not a software application. The description focuses on material and physical testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The description clearly states this is a "surgeon's glove" intended to be worn by operating room personnel to "protect a surgical wound from contamination." This is a barrier device used on the body (or to protect the body) during a medical procedure.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. The testing mentioned is related to the glove's barrier properties against chemotherapy drugs, which is a performance characteristic, not a diagnostic function.
Therefore, based on the provided information, this surgeon's glove is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tested for use with Chemotherapy Drugs per ASTM D6978-05.
For Carmustine (BCNU), 3.3mg/ml (3,300 ppm), the minimum breakthrough detection was 6.9 minutes (Specimen 1/2/3: 9.0, 12.3, 6.9).
For Thiotepa, 10.0 mg/ml (10,000 ppm), the minimum breakthrough detection was 7.6 minutes (Specimen 1/2/3: 9.2, 7.6, 10.0).
For the remaining 30 listed chemotherapy drugs, there was "No Breakthrough up to 240 min."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 9, 2018
Lucenxia Prescience AG Robert Hill Regulatory Director Rathausstrasse 7 Baar, CH6341, Switzerland
Re: K173386
Trade/Device Name: Finessis Zero Flexylon Powder Free Sterile White Surgical Gloves, Tested for use with Chemotherapy Drugs
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: March 1, 2018 Received: March 5, 2018
Dear Robert Hill:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Geeta K. Pamidimukkala -5 for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173386
Device Name
Finessis Zero Flexylon Powder Free Sterile White Surgical gloves Tested for use with Chemotherapy Drugs
Indications for Use (Describe)
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.
| Tested Chemotherapy Drug
and Concentration per ASTM D6978-05 | Minimum BREAKTHROUGH DETECTION
(Specimen 1/2/3) (Minutes) |
|-----------------------------------------------------------------|--------------------------------------------------------------|
| 1 Carmustine (BCNU), 3.3mg/ml (3,300 ppm) | 6.9 (9.0, 12.3, 6.9) |
| 2 Cisplatin, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min. |
| 3 Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm) | No Breakthrough up to 240 min. |
| 4 Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | No Breakthrough up to 240 min. |
| 5 Doxorubicin Hydrochloride, 2.0mg/ml (2,000 ppm) | No Breakthrough up to 240 min. |
| 6 Etoposide (Toposar), 20.0 mg/ml (20,000 ppm) | No Breakthrough up to 240 min. |
| 7 Fluorouracil, 50.0 mg/ml (50,000 ppm) | No Breakthrough up to 240 min. |
| 8 Ifosfamide, 50.0 mg/ml (50,000 ppm) | No Breakthrough up to 240 min. |
| 9 Methotrexate, 25 mg/ml (25,000 ppm) | No Breakthrough up to 240 min. |
| 10 Mitomycin C, 0.5 mg/ml (500 ppm) | No Breakthrough up to 240 min. |
| 11 Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm) | No Breakthrough up to 240 min. |
| 12 Thiotepa, 10.0 mg/ml (10,000 ppm) | 7.6 (9.2, 7.6, 10.0) |
| 13 Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min. |
| 14 Bleomycin, 15 mg/ml (15,000 ppm) | No Breakthrough up to 240 min. |
| 15 Busulfan, 6 mg/ml (6,000 ppm) | No Breakthrough up to 240 min. |
| 16 Carboplatin, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min. |
| 17 Cytarabine, 100 mg/ml (100,000 ppm) | No Breakthrough up to 240 min. |
| 18 Daunorubicin, 5 mg/ml (5,000 ppm) | No Breakthrough up to 240 min. |
| 19 Docetaxel, 10.0 mg/ml (10,000 ppm) | No Breakthrough up to 240 min. |
| 20 Epirubicin, 2.0 mg/ml (2,000 ppm) | No Breakthrough up to 240 min. |
| 21 Fludarabine, 25 mg/ml (25,000 ppm) | No Breakthrough up to 240 min. |
| 22 Ganciclovir, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min. |
| 23 Gemcitabine (Gemzar), 38 mg/ml (38,000 ppm) | No Breakthrough up to 240 min. |
| 24 Idarubicin, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min. |
| 25 Irinotecan, 20.0 mg/ml (20,000 ppm) | No Breakthrough up to 240 min. |
| 26 Mechlorethamine HCI, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min. |
| 27 Melphalan, 5.0 mg/ml (5,000 ppm) | No Breakthrough up to 240 min. |
| 28 Mitoxantrone, 2.0 mg/ml (2,000 ppm) | No Breakthrough up to 240 min. |
| 29 Oxaliplatin, 2.0 mg/ml (2,000 ppm) | No Breakthrough up to 240 min. |
| 30 Rituximab, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min. |
| 31 Trisenox, 0.1 mg/ml (100 ppm) | No Breakthrough up to 240 min. |
| 32 Vinorelbine, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min. |
TIME
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
3
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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