(441 days)
Not Found
No
The summary describes a physical surgical suture with barbs and a needle. There is no mention of software, algorithms, data processing, or any other components that would suggest the use of AI or ML. The performance studies focus on material properties, biocompatibility, and mechanical strength, not algorithmic performance.
No.
The device is a surgical suture used for soft tissue approximation, which is a structural rather than a therapeutic function.
No
The device, Miracu™ barbed surgical suture, is described as a surgical suture for soft tissue approximation. Its intended use focuses on physically bringing tissues together, not on diagnosing medical conditions.
No
The device description clearly states it is a physical surgical suture with a needle, made of polydioxanone, and includes details about its physical characteristics, sterilization, and mechanical properties. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Miracu™ barbed surgical suture is a physical device used for soft tissue approximation (stitching) on the skin. It is a surgical tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "soft tissue approximation where use of an absorbable suture is appropriate" and "on the skin for dermatological applications only." This describes a surgical procedure, not a diagnostic test.
Therefore, the Miracu™ barbed surgical suture falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Miracu™ barbed surgical suture is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not interior body cavity applications and the suture is not intended for lifting and supporting tissues.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
Miracu™ synthetic barded surgical absorbable polydioxanone (PDO) suture with needle is straight, hollow, cannula and is pre-loaded onto the suture. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.
Each dyed (violet) suture has bi-directional barbs along axis of the suture monofilament. The Miracu™ Synthetic Absorbable PDO suture with needle approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 4-0, 3-0, and 0, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP).
The Miracu™ is barbed to two sections on suture and the barbs on each section are opposite direction each other. The reason this suture has opposite barb direction is not to have type of movement described as sliding back and forth. Therefore, the effectiveness of suture for treatment is improved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin for dermatological applications only
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)
Laboratory testing regarding characteristics was performed on the Miracu™ to verify its safety and performance.
BIOCOMPATIBILITY
A biocompatibility assessment was performed on the patient contact materials of Miracu™ in accordance with ISO 10993-1:2009 standard. The test results generated from intracutaneous, acute systemic toxicity, cytotoxicity, bacteria reverse mutation study, implantation, subchronic, and sensitization, bacterial endotoxin - Limulus Amoebocyte Lysate (LAL) and material-mediated pyrogen (rabbit) tests supports assessment of biocompatibility for this medical device.
BENCH (PERFORMANCE TESTING) MECHANICAL TESTING
Tests were performed in accordance with USP 37-NF 32:2014 dimension test, tensile strength, sutures, absorbable surgical suture, and ASTM F1874-98 9 reapproved 2011 standard test method for bend testing of needles used in surgical sutures. All the test results have met their respective acceptance criteria.
ANIMAL STUDIES (PERFORMANCE TESTING)
Animal studies were presented under an assessment of In-vivo biodegradation of absorbable Miracu™ suture Miracu™ in comparison with the predicate device TranQuill Barbed Device (reference samples predicate device) over time in Sprague-Dawley rat animal model system.
The study was carried out to evaluate the biodegradation of absorbable suture in Sprague-Dawley rats for a total of 12 weeks, after multiple 2 week interval examinations following necropsies. This study was performed in accordance with the USP 37 NF:2014 standards: absorbable surgical suture, tensile strength, sutures – diameter, and their acceptance criteria were met. Other parameters under investigation barb holding forces, residual tensile strength, and absorption (loss of mass) were demonstrated to reflect the biodegradation levels (indicators) over time were numerical determined. No significant differences between all test groups and reference groups (predicate device) in all necropsy groups were evident. The Miracu™ performance was substantially equivalent to the predicate device.
CLINICAL STUDIES (PERFORMANCE TESTING)
Clinical studies were not performed nor required.
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
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
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November 14, 2018
Feeltech Co., Ltd. % Dr. Albert Rego Consultant Albert Rego, Ph.D., Inc. 27001 La Paz Rd. #314 Mission Viejo, California 92691
Re: K172602
Trade/Device Name: Miracu Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: October 15, 2018 Received: October 17, 2018
Dear Dr. Rego:
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. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
David Krause -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) K172602
Device Name Miracu™M barbed surgical suture
Indications for Use (Describe)
The Miracu™ barbed surgical suture is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not interior body cavity applications and the suture is not intended for lifting and supporting tissues.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
3
Image /page/3/Picture/0 description: The image shows the logo for Feeltech. The logo is in black and blue. The word "Feeltech" is in bold, black letters, with a blue plus sign in the middle of the word. Below the word "Feeltech" is the text "(주) 필텍" in a smaller font.
#3F, 4F, 15, Jayumuyeok2-gil, Gunsan-si, Jeollabuk-do, Korea Tel: +82 63 468 6626 Fax:+82 63 468 6623
510(k) Summary (As required by 21 CFR 807.92)
| I. SUBMITTER: | Feeltech Co., Ltd.
3, 4 Floor, Standard Factory 2-Dong,
15, Jayumuyeok 2-gil, Gunsan-si, Jellabuk-do, 573-540 KOREA
Tel.: +82 63 468-6626
Fax: +82 63 468-6623 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Phone: | Jake Choi
+82 31 628-8560 |
| Date Prepared: | November 7, 2018 |
| II. DEVICE: | |
| Trade Name: | Miracu™ (Miracu™ barbed surgical suture) |
| Common Name: | Absorbable Polydioxanone Suture with Needle |
| Classification Name: | Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840) (NEW) |
| Regulatory Class: | Class II |
| Classification Product Code: | NEW |
III. PREDICATE DEVICE:
| 510(k) Number: | K133420 |
|---|---|
| Product Name: | TranQuill Barbed Device |
| Manufacturer: | Surgical Specialties Corp |
IV. DEVICE DESCRIPTION:
Miracu™ synthetic barded surgical absorbable polydioxanone (PDO) suture with needle is straight, hollow, cannula and is pre-loaded onto the suture. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.
Each dyed (violet) suture has bi-directional barbs along axis of the suture monofilament. The Miracu™ Synthetic Absorbable PDO suture with needle approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 4-0, 3-0, and 0, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP).
4
#3F, 4F, 15, Jayumuyeok2-gil, Gunsan-si. Jeollabuk-do. Korea Tel: +82 63 468 6626 Fax:+82 63 468 6623
The Miracu™ is barbed to two sections on suture and the barbs on each section are opposite direction each other. The reason this suture has opposite barb direction is not to have type of movement described as sliding back and forth. Therefore, the effectiveness of suture for treatment is improved.
While the formation of barbs in the Miracu™ reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the Miracu™ can be compared with USP knot strength of nonbarbed suture as defined in the tale below.
| Tensile Strength - USP criteria vs Actual (Barbed from USP Suture size) | ||||
|---|---|---|---|---|
| USP Suture | ||||
| Size | USP | |||
| Criteria | ||||
| (kgf) | Actual | |||
| Suture | ||||
| Tensile | ||||
| Strength |
- barbed
(kgf) | Actual
Suture
Tensile
Strength -
-barbed
(N) | Miracu™
Tissue
Device
Equivalent
Size |
| 4-0 | 1.20 | 0.95 | 9.32 | 5-0 |
| 3-0 | 1.90 | 1.77 | 17.4 | 4-0 |
| 2-0 | 2.90 | 2.68 | 26.2 | 3-0 |
| 0 | 4.10 | 3.90 | 38.2 | 2-0 |
| 2 | 6.60 | 6.35 | 62.3 | 1 |
TENSILE STRENGTH
V. INDICATIONS FOR USE
The Miracu™ barbed surgical suture comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
VI. TECHNOLOGICAL CHARACTERISTICS:
Miracu™ has the same fundamental scientific technology as the TransQuill Barbed Device Absorbable Surgical Suture, K133420.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison of features and operation principles between Miracu™ from Feeltech Co. Ltd., and TranQuill Barbed Device (K133420) from Surgical Specialties Corp. is listed as follows:
5
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#3F, 4F, 15, Jayumuyeok2-gil, Gunsan-si, Jeollabuk-do, Korea
Tel: +82 63 468 6626 Fax:+82 63 468 6623
| Category | Candidate Device
Miracu™ | Predicate Device
TranQuill Barbed Device
Absorbable
Surgical Suture, K133420 | Substantially Equivalent
or Not Substantially
Equivalent |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Suture Absorbable Synthetic
Polydioxanone with Needle
Suturing Disposable | Polydioxanone Absorbable
Surgical Suture | Substantially Equivalent |
| Manufacturer | Feeltech Co., Ltd. | Surgical Specialties Corporation | Not Applicable |
| 510(k) Number | K172602 | K133420 | Not Applicable |
| Indication for Use | The Miracu™ barbed surgical
suture is comprised of dyed
polydioxanone, is indicated for soft
tissue approximation where use of
an absorbable suture is
appropriate. The anatomical
location(s) of use are on the skin
for dermatological applications
only. The suture is not intended for
interior body cavity applications
and the suture is not intended for
lifting and supporting tissues. | The TransQuill barbed device
comprised of dyed PDO is
indicated for use in soft tissue
approximation where use of
absorbable sutures is
appropriate. | Indications for Use
Similar with respect to
usage on soft tissue
approximation.
Different in that the
Miracu™ is specific to
usage on the skin for
dermatological
applications, where the
predicate is not
restricted in the
Indication for Use.
Substantially Equivalent
Design
Similar in usage of suture
type and application.
Different in Interval
between barbed sections
from 10mm for Miracu™
and 25mm for the
predicate.
Substantially Equivalent |
| Sterile | E.O. Sterile | E.O. Sterile | Substantially Equivalent |
| Configuration | PDO Suture and Needle. The
subject device is pre-loaded with a
hollow needle and is not swaged. | PDO Suture and Needle.
predicate suture being swaged
to a standard suturing needle | Design
Similar in usage of suture
type and application.
Different in_Interval
between barbed sections
from 10mm (7 barbs per
10mm length) for
Miracu™ and 25mm (16
barbs per 10mm length)
for the predicate.
Substantially Equivalent |
| Materials | Poly(1,4-dioxanone-2-one)
0.003g/g | Poly (dioxanone) | Substantially Equivalent |
| Category | Candidate Device
Miracu™ | Predicate Device
TranQuill Barbed Device
Absorbable
Surgical Suture, K133420 | Substantially Equivalent
or Not Substantially
Equivalent |
| Color | Dyed suture (Violet) (0.0250.075%45° | 2~45° | Substantially Equivalent |
w/w) | Dyed (violet) | Substantially Equivalent |
| Absorbable | Absorbable | Absorbable | Substantially Equivalent |
| Braid/Monofilament | Monofilament | Monofilament | Substantially Equivalent |
| Suture Size | 4-0, 3-0, 2-0, & 0 | 4-0, 3-0, 2-0, 0, 1, & 2 | Substantially Equivalent |
| Length of Suture1 | 90, 110, and 150 mm | 140 mm ( 70 mm x 70 mm ), 70
mm (35 mm x 35 mm), 280 mm
(140 mm x 140 mm), 480 mm
(240 mm x 240 mm), 200 mm
(100 mm x 100 mm), 800 mm
(400 mm x 400 mm), 600 mm
(300 mm x 300 mm), 720 mm
(360 mm x 360 mm), & 900 mm
(450 mm x 45 mm) | Substantially Equivalent |
| Needle Material | Stainless Steel | Stainless Steel | Substantially Equivalent |
| Barb per the Linear
Length of Suture | Barbed | Barbed | Substantially Equivalent |
| Barb angle | 2
| Biocompatible | Yes | Yes | Substantially Equivalent |
6
Image /page/6/Picture/1 description: The image shows the logo for Feeltech. The logo is in black font, with a blue plus sign in the middle. Underneath the logo is the text "(주) 필텍".
#3F, 4F, 15, Jayumuyeok2-gil, Gunsan-si, Jeollabuk-do, Korea Tel: +82 63 468 6626 Fax:+82 63 468 6623
¹ Both the Subject and the Predicate devices have a barb configuration.
VIII. PERFORMANCE DATA
Laboratory testing regarding characteristics was performed on the Miracu™ to verify its safety and performance.
BIOCOMPATIBILITY
A biocompatibility assessment was performed on the patient contact materials of Miracu™ in accordance with ISO 10993-1:2009 standard. The test results generated from intracutaneous, acute systemic toxicity, cytotoxicity, bacteria reverse mutation study, implantation, subchronic, and sensitization, bacterial endotoxin - Limulus Amoebocyte Lysate (LAL) and material-mediated pyrogen (rabbit) tests supports assessment of biocompatibility for this medical device.
BENCH (PERFORMANCE TESTING)
MECHANICAL TESTING
Tests were performed in accordance with USP 37-NF 32:2014 dimension test, tensile strength, sutures, absorbable surgical suture, and ASTM F1874-98 9 reapproved 2011 standard test method for bend testing of needles used in surgical sutures. All the test results have met their respective acceptance criteria.
7
Image /page/7/Picture/0 description: The image shows the logo for Feeltech. The word "Feeltech" is written in a bold, sans-serif font, with the "t" in "Feeltech" replaced by a blue plus sign. A blue curved line is above the word "Feeltech". Below the word "Feeltech" is the text "(주) 필텍".
#3F, 4F, 15, Jayumuyeok2-gil, Gunsan-si. Jeollabuk-do. Korea Tel: +82 63 468 6626 Fax:+82 63 468 6623
ANIMAL STUDIES (PERFORMANCE TESTING)
Animal studies were presented under an assessment of In-vivo biodegradation of absorbable Miracu™ suture Miracu™ in comparison with the predicate device TranQuill Barbed Device (reference samples predicate device) over time in Sprague-Dawley rat animal model system.
The study was carried out to evaluate the biodegradation of absorbable suture in Sprague-Dawley rats for a total of 12 weeks, after multiple 2 week interval examinations following necropsies. This study was performed in accordance with the USP 37 NF:2014 standards: absorbable surgical suture, tensile strength, sutures – diameter, and their acceptance criteria were met. Other parameters under investigation barb holding forces, residual tensile strength, and absorption (loss of mass) were demonstrated to reflect the biodegradation levels (indicators) over time were numerical determined. No significant differences between all test groups and reference groups (predicate device) in all necropsy groups were evident. The Miracu™ performance was substantially equivalent to the predicate device.
CLINICAL STUDIES (PERFORMANCE TESTING)
Clinical studies were not performed nor required.
IX. CONCLUSIONS
The device description, indications for use, technology, design of Miracu™ and the predicate device are similar, with the configuration differences described above. The performance testing data demonstrated substantial equivalence to the predicate device. This regulatory submission presents evidence and concludes this subject medical device, Miracu™ is substantially equivalent to the predicate device.