(116 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is described as facilitating surgical fixation of sutures to anatomical structures, which is a therapeutic intervention.
No
The Saffron Fixation System is described as a device for attaching suture to ligaments, functioning as an implantable tissue fixation system. Its purpose is to physically fix tissue, not to diagnose a medical condition.
No
The device description clearly outlines physical components: a single-use disposable delivery tool and implantable tissue fixation anchors made of polysulfone. Performance studies also focus on mechanical, biocompatibility, and sterilization aspects of these physical components.
Based on the provided information, the Saffron™ Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "attaching suture to ligaments of the pelvic floor." This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device consists of a delivery tool and implantable anchors. These are designed for physical fixation within the body, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status
The Saffron™ Fixation System is a surgical device used for tissue repair and support.
N/A
Intended Use / Indications for Use
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
Product codes
PBQ
Device Description
The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament..
The physician transvaginally inserts the distal end of the delivery tool with a loaded anchor through the dissected tissue to the desired location. The physician manually positions the tip of the distal end at the location where the anchor is to be placed and manually presses the plunger advancing the cannula in the fixation tool and releasing the anchor into the tissue. The anchor penetrates the chosen landmark to provide a permanent fixation point for the loaded suture.
The Saffron Fixation device is a single use device which is supplied sterile. The Saffron Anchor is an implantable device which is supplied sterile. The Saffron Fixation System has a shelf life of 6 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
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
Biocompatibility Testing:
Evaluated for cytotoxicity, sensitization, intracutaneous reactivity irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity with intramuscular implantation, genotoxicity, and implantation based on ISO 10993-1 (2020) and FDA Guidance. Chemical characterization and toxicological risk assessment were completed on the anchor for chronic toxicity and carcinogenicity.
Mechanical/Performance Testing:
Anchor penetration force, Anchor detachment force, Cannula compressive strength, Anchor eyelet strength, Anchor holding force, Anchor insertion force, Anchor tab torque strength, Anchor tab shear strength, Anchor tab fracture strength, Anchor tab removal force, Anchor eyelet/suture compatibility, Anchor eyelet capacity, Anchor MR compatibility assessment, Shaft rotation, Delivery device maximum actuation force, Delivery device feedback force, Delivery device minimum actuation force, Delivery device shaft stiffness, Delivery device torque strength, Delivery device tensile strength, Delivery device plunger strength, Visual and dimensional testing of the anchor and delivery device, Label and barcode evaluation, Sterile barrier seal strength, Sterile barrier integrity after aging, Full package integrity after transportation simulation per ASTM D4169-16, Shelf Life/Expiration date, Usability testing per the 2016 FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices, Non-clinical Cadaver testing.
Sterilization:
Validated ethylene oxide sterilization cycle with a sterility assurance level (SAL) of 10-6 per ISO 11135:2014 and 2016 FDA guidance.
Packaging and Distribution:
Subjected to packaging performance and stability testing per ISO 11607-1:2019, demonstrating integrity through transportation and storage for a 6-month shelf life.
Animal/Clinical Testing:
No animal studies or clinical testing were provided.
Key results: The Saffron™ Tissue Fixation System has been demonstrated to be substantially equivalent to the predicate, Anchorsure, cleared under premarket notification number K120831, based on the non-clinical performance data provided. The Saffron™ Fixation System is as safe and effective as the predicate device to support a substantial equivalence determination.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 10, 2022
Coloplast A/S Gayatri Ghadge Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K220420
Trade/Device Name: Saffron™ Fixation System Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: PBQ Dated: May 9, 2022 Received: May 10, 2022
Dear Gayatri Ghadge:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220420
Device Name Saffron™ Fixation System
Indications for Use (Describe)
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| I.
SUBMITTER
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Office: 612-422-3206 |
| Email: usggh@coloplast.com | |
| Name of Contact Person: | Gayatri Ghadge |
| Principal Regulatory Affairs Specialist | |
| Address/Contact: | 1601 West River Road North |
| Minneapolis, MN 55411 | |
| Date Prepared: | June 7, 2022 |
| II. | |
| DEVICE | |
| Trade or Proprietary Name: | Saffron™ Fixation System |
| Common or Usual Name: | |
| Regulation Number: | |
| Regulation Name: | |
| Product Code: | Pelvic ligament fixation system |
| 21 CFR 884.4530 | |
| Obstetric-gynecologic specialized manual instrument | |
| PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic | |
| Use) | |
| Regulatory Class: | II |
III. PREDICATE DEVICE
Anchorsure, 510(k)-cleared on October 12, 2012 under K120831.
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament..
4
The physician transvaginally inserts the distal end of the delivery tool with a loaded anchor through the dissected tissue to the desired location. The physician manually positions the tip of the distal end at the location where the anchor is to be placed and manually presses the plunger advancing the cannula in the fixation tool and releasing the anchor into the tissue. The anchor penetrates the chosen landmark to provide a permanent fixation point for the loaded suture.
The Saffron Fixation device is a single use device which is supplied sterile. The Saffron Anchor is an implantable device which is supplied sterile. The Saffron Fixation System has a shelf life of 6 months.
V. INDICATIONS FOR USE
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
| VI. | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE |
|---|---|
| PREDICATE DEVICE |
| Subject Device | Predicate Device | |
|---|---|---|
| Saffron Fixation System | Anchorsure | |
| K220420 | K120831 | |
| Regulation | ||
| Number | 21 CFR 884.4530 | 21 CFR 884.4530 |
| Product Code | PBQ | PBQ |
| Indications for | ||
| Use | The Saffron™ Fixation System is | |
| indicated for attaching suture to | ||
| ligaments of the pelvic floor. | Anchorsure is indicated for | |
| attaching suture to ligaments of the | ||
| pelvic floor. | ||
| Target Structures | Pelvic floor ligaments | Pelvic floor ligaments |
| Anchor | ||
| Placement | ||
| Duration | Permanent Implant | Permanent Implant |
| Anchor Materials | Polysulfone, titanium oxide | |
| colorant | Polyether ether ketone (PEEK) | |
| Anchor | ||
| Dimensions | Length: 9.29 mm | |
| Height: 3.44 mm | ||
| Width: 1.65 mm | Diameter: 3 mm | |
| Length: 7 mm | ||
| Delivery System | ||
| Materials | Polypropylene (plunger), | |
| polycarbonate (handle), stainless | ||
| steel 304 (shaft), polycarbonate / | ||
| acrylonitrile butadiene styrene | ||
| (ABS) (distal tip) | Stainless steel 303, | |
| polyoxymethylene | ||
| Delivery System | ||
| Dimensions | Fixation Tool shaft diameter: 4 mm | |
| Fixation Tool shaft length: 200 mm | Anchoring Handle tube diameter: 6 | |
| mm | ||
| Anchoring Handle tube length: 204 | ||
| mm | ||
| Accessories | ||
| Provided | No, compatible with any suture | |
| size 0 or smaller | Yes, USP size 0 polypropylene | |
| suture and curved stainless steel |
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| surgical needle | ||
|---|---|---|
| Sterile | Yes, ethylene oxide | Yes, ethylene oxide |
Saffron Fixation System and the Anchorsure are both permanent anchoring devices that can be used to secure the suture to pelvic floor ligaments. Saffron has the same intended use, target population, sterilization technique, and duration of use as the predicate device. The differences between the two devices are the dimensions, provided accessories, anchor and delivery system design, and component materials. These differences do not raise different questions of safety or effectiveness. These differences were evaluated with performance testing to demonstrate substantial equivalence to the predicate device.
PERFORMANCE DATA VII.
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2020): Biological evaluation of medical devices – Part 1: "Evaluation and testing within a risk management process" and FDA Guidance for Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff - September 4, 2020. The delivery tool was evaluated for the following biocompatibility endpoints, in accordance with an external communicating device contacting tissue/bone/dentin for a limited duration (≤ 24 hours):
- Cytotoxicity per ISO 10993-5:2009 ●
- Guinea Pig Maximization Sensitization per ISO 10993-10:2010 ●
- Intracutaneous Reactivity Irritation per ISO 10993-10:2010 ●
- Acute Systemic Toxicity per ISO 10993-11:2017 ●
- . Material-Mediated Pyrogenicity per USP
The anchor was evaluated for the following biocompatibility endpoints, in accordance with an implant device contacting tissue/bone for a permanent duration:
- Cytotoxicity per ISO 10993-5:2009
- Guinea Pig Maximization Sensitization per ISO 10993-10:2010
- Intracutaneous Reactivity Irritation per ISO 10993-10:2010 .
- Acute Systemic Toxicity per ISO 10993-11:2017 ●
- Material-Mediated Pyrogenicity per USP ●
- . Subacute/subchronic toxicity with intramuscular implantation per ISO 10993-11:2017
- Genotoxicity per ISO 10993-3:2014
- Implantation per ISO 10993-6:2016 ●
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Chemical characterization and toxicological risk assessment in accordance with ISO 10993-18:2020 was completed on the anchor to address the biocompatibility endpoints of:
- Chronic toxicity
- . Carcinogenicity
Mechanical/ Performance Testing
The below testing was performed:
- Anchor penetration force ●
- Anchor detachment force ●
- Cannula compressive strength
- Anchor eyelet strength ●
- Anchor holding force
- Anchor insertion force
- Anchor tab torque strength
- Anchor tab shear strength
- Anchor tab fracture strength
- Anchor tab removal force
- Anchor eyelet/suture compatibility ●
- Anchor eyelet capacity
- Anchor MR compatibility assessment per 2014 FDA guidance document Establishing ● Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
- Shaft rotation
- Delivery device maximum actuation force ●
- Delivery device feedback force
- Delivery device minimum actuation force ●
- Delivery device shaft stiffness
- Delivery device torque strength
- Delivery device tensile strength
- Delivery device plunger strength
- Visual and dimensional testing of the anchor and delivery device ●
- Label and barcode evaluation
- Sterile barrier seal strength
- Sterile barrier integrity after aging
- Full package integrity after transportation simulation per ASTM D4169-16
- Shelf Life/Expiration date
- Usability testing per the 2016 FDA guidance document Applying Human Factors and ● Usability Engineering to Medical Devices
- Non-clinical Cadaver testing
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Sterilization
The Saffron Fixation System is sterilized using ethylene oxide in a validated cycle, demonstrating a sterility assurance level (SAL) of 106. Sterilization was completed per ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices and summarized in accordance with the 2016 FDA guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Packaging and Distribution
The Saffron Fixation System was subjected to packaging performance and stability testing to establish compliance with ISO 11607-1:2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems". Results of testing demonstrate that the sterile barrier packaging systems can withstand the hazards of climatic stressing, transportation, and storage while adequately maintaining the functional integrity of the product and sterile barrier integrity throughout the product's shelf life of 6 months.
Animal/Clinical Testing
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
VIII. CONCLUSIONS
The Saffron™ Tissue Fixation System has been demonstrated to be substantially equivalent to the predicate, Anchorsure, cleared under premarket notification number K120831, based on the non-clinical performance data provided. The Saffron™ Fixation System is as safe and effective as the predicate device to support a substantial equivalence determination.