(81 days)
Not Found
No
The summary describes a surgical sponge and its material composition, with no mention of AI or ML technology.
No.
The device's intended use is to protect nervous tissue, absorb fluids, or stop bleeding during surgery, which are supportive functions rather than direct therapeutic actions to treat or cure a disease.
No
The device is a surgical sponge used during surgery to protect nervous tissue, absorb fluids, or stop bleeding. Its function is therapeutic/supportive, not diagnostic. While it is x-ray detectable, this is a safety feature, not a diagnostic one.
No
The device is a physical surgical sponge made of fibers, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding. This is a direct therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a surgical sponge, a physical device used within the body during a procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on biocompatibility and comparability of materials, which are relevant to a surgical device, not a diagnostic test.
IVD devices are 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 device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Product codes (comma separated list FDA assigned to the subject device)
HBA
Device Description
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The Delicot product line is made from lyocell, a manmade fiber derived from cellulose, better known under the brand name of Tencel - a type of rayon; it is supplied in various lengths and widths and has been marketed since 1990. The Delicot product line is one of three rayon-based sponges. The Delicot sponges are manufactured using Dupont Style 8623 consisting of 100% lyocell. Dupont has discontinued the manufacture of Style 8623. Dupont Style 8471 consisting of 58% polyester and 42% lyocell is our proposed replacement.
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)
Biocompatibility Testing:
Biocompatibility testing included Cytotoxicity and was completed in accordance with FDA's Blue Book Guidance G95-1 ("Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' "). The results of the study demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge. The study was conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58.
Performance Standards:
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, American Surgical Company conducted comparability testing on the existing Delicot sponge and the Delicot sponge with the replacement material.
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.
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
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).
0
12/822
510(k) Summary SEP 1 0 2012 510(K) Owner: American Surgical Company, LLC (formerly American Surgical Sponges, LLC and American Silk Sutures Inc.) 82 Sanderson Avenue Lynn, MA 01902 781-592-7200 Owner/Operator Number: 10030544 Submitter: Cheryl Marotta American Surgical Company 82 Sanderson Avenue Lynn, MA 01902 Telephone: 781-592-7200 Email: cheryl.marotta@americansurgical.com Contact: Erik Piasio Managing Director Tel: 781-592-7200 Fax: 781-595-5460 Email: erik.piasio@americansurgical.com Manufacturer: American Surgical Company, LLC 82 Sanderson Avenue, Suite 212 Lynn, MA 01902 781-592-7200 Registration Number: 1221144 Date Prepared: 8 June 2012 Delicot Surgical Sponge Trade name: Common name: Neurosurgical Paddie or Sponge Classification name: 21 CFR § 882.4700 Product Code(s): HBA (neurosurgical paddie) Classification: Class II Current Legally Marketed Device: Ray-Cot, Uniqcot and Delicot Neurosurgical Sponges K902921
American Surgical Company Special 1 510(k)
1
X121822
Policot Neurosurgical Sponge K862494
Summarv Description of the Device:
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The Delicot product line is made from lyocell, a manmade fiber derived from cellulose, better known under the brand name of Tencel - a type of rayon; it is supplied in various lengths and widths and has been marketed since 1990. The Delicot product line is one of three rayon-based sponges. The Delicot sponges are manufactured using Dupont Style 8623 consisting of 100% lyocell. Dupont has discontinued the manufacture of Style 8623. Dupont Style 8471 consisting of 58% polyester and 42% lyocell is our proposed replacement.
Intended Use:
The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Indications for Use:
The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Substantial Equivalence:
The modified Delicot Neurosurgical Sponges are equivalent to the previously cleared 510(k) (K902921 Sept. 18, 1990 and K862494 July 30, 1986) as these devices:
- have the same indications for use and intended use, ●
- use the same principle of operation. .
- . incorporate the same basic design,
- . incorporate equivalent materials,
- . have the same shelf life, and
- . are packaged and sterilized using the same materials and processes.
In summary, the modification to the Delicot Neurosurgical Sponges described in this submission is substantially equivalent to the predicate device.
Biocompatibility Testing:
American Surgical Company Special 2 510(k)
2
Biocompatibility testing included Cytotoxicity and was completed in accordance with FDA's Blue Book Guidance G95-1 ("Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' "). The results of the study demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge. The study was conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58.
Performance Standards:
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, American Surgical Company conducted comparability testing on the existing Delicot sponge and the Delicot sponge with the replacement material.
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 caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Surgical Company, LLC c/o Mr. Erik Piasio 82 Sanderson Avenue Lynn, MA 01902
SEP 10 2012
Re: K121822
Trade/Device Name: Delicot Surgical Sponge Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical Paddie Regulatory Class: Class II Product Code: HBA Dated: August 13, 2012 Received: August 16, 2012
Dear Mr. Piasio:
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.
4
Page 2 - Mr. Erik Piasio
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1.0 Indications for Use
510(k) Number (if known): K121822
Device Name:
Delicot Neurosurgical Sponge
Indications for Use: The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| JOE HUTTER | ||
| (Division Sign-Off) | ||
| Division of Ophthalmic, Neurological and Ear, | ||
| Nose and Throat Devices | ||
| American Surgical Company | 1-1 | V171822 |
. American Surgical Company Special 510(k)
510(k) Number.
KIZ|822