(106 days)
No
The summary describes a surgical mesh and introducer system for pelvic organ prolapse repair, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the repair of pelvic organ prolapse, which is a medical condition, and its use is intended to restore or improve physiological function, thus fulfilling the definition of a therapeutic device.
No
The device is described as a "Pelvic Floor Repair System" consisting of mesh implants and introducers for the repair of pelvic organ prolapse. Its function is to rectify a physical condition, not to identify or analyze one.
No
The device description explicitly states it consists of "macroporous, monofilament, polypropylene mesh implants and a set of reusable introducers," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of pelvic organ prolapse. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a mesh implant and introducers used for surgical placement. This is a physical implant and surgical tools, not a reagent, instrument, or system intended for the examination of specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases, monitor health, or screen for conditions. This device is a surgical implant used for structural repair.
N/A
Intended Use / Indications for Use
Ascend AC (anterior compartment) and Ascend PC (posterior compartment) are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.
Product codes
OTP
Device Description
The Ascend Pelvic Floor Repair System consists of macroporous, monofilament, polypropylene mesh implants and a set of reusable introducers to facilitate mesh implant placement. The reusable introducers are available separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic organ
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)
The mesh used in the Ascend device has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical testing and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AMS Apogee Vault Suspension System K040537, AMS Perigee System K040623
Reference Device(s)
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
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
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K083722 Page 1/2
& CALDERA MEDICAL
510(k) Summary
| Date of Summary: | December 12, 2008 | MAR 31 2009 |
|---|---|---|
| Applicant: | Caldera Medical, Inc. | |
| 28632 Roadside Drive, Suite 260 | ||
| Agoura Hills, CA 91301 | ||
| P 866.422.5337 | ||
| F 818.879.6556 | ||
| Contact: | Mara Korsunsky | |
| Quality Assurance and Regulatory Affairs Manager | ||
| P 818.879.6555 x 105 | ||
| F 818.879.6556 | ||
| E mkorsunsky@calderamedical.com | ||
| Device Name: | Surgical Mesh (878.3300) | |
| Trade Name: | Ascend | |
| Common Name: | Surgical Mesh | |
| Predicate Device: | AMS Apogee Vault Suspension System K040537 | |
| AMS Perigee System K040623 | ||
| Description of Device: | The Ascend Pelvic Floor Repair System consists of | |
| macroporous, monofilament, polypropylene mesh implants | ||
| and a set of reusable introducers to facilitate mesh implant | ||
| placement. The reusable introducers are available | ||
| separately. | ||
| Intended Use of Device: | Ascend AC (anterior compartment) and Ascend PC | |
| (posterior compartment) are indicated for repair of pelvic | ||
| organ prolapse, including anterior, posterior, vaginal vault | ||
| and uterine prolapse. |
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K083722 page 2/2
CALDERA MEDICAL
Summary of Technological Characteristics:
The mesh used in the Ascend device has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical testing and biocompatibility.
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Image /page/2/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 abstract symbol resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Caldera Medical, Inc. c/o Ms. Mara Korsunsky QA/RA Manager 28632 Roadside Drive, Suite 260 AGOURA HILLS CA 91301
SEP 2 8 2012
Re: K083722
Trade/Device Name: Ascend Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 18, 2009 Received: March 19, 2009
Dear Ms. Korsunsky:
This letter corrects our substantially equivalent letter of March 31, 2009.
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 (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.
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
3
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" (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.
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,
Sincerely yours,
Benjamin R. Civiletti
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left and the text "CALDERA MEDICAL" on the right. The text is in a bold, sans-serif font and is all uppercase.
Indications for Use
510(k) Number (if known): K083722
Device Name: Ascend
Indications for Use:
Ascend AC and Ascend PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.
Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use [] (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)
David Kraefer for MXM March 31, 2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083722
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