(128 days)
Not Found
No
The summary describes a mechanical surgical device for anchoring sutures and does not mention any AI/ML components or functions.
No
The device is described as an instrument for attaching sutures to ligaments of the pelvic floor, which is a surgical tool rather than a device intended for therapeutic treatment of a disease or condition.
No
The device is indicated for "attaching sutures to ligaments of the pelvic floor," which is a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it is a "single use instrument" comprising physical components (anchor-suture unit, applicator, thimble) and the performance studies detail testing of physical properties like biocompatibility, corrosion, strength, and sterilization, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "attaching sutures to ligaments of the pelvic floor." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an instrument for anchoring sutures, comprising an anchor-suture unit, applicator, and thimble. This is a surgical tool.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests in vitro (in glass, or outside the body) on specimens taken from the human body. This device is used in vivo (in the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
Product codes
PBQ
Device Description
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The NeuGuide has undergone and successfully passed performance testing as follows:
- Biocompatibility (Cytotoxicity, intracutaneous reactivity, sensitization, implantation, acute systemic toxicity, Extractable and Leachable testing with risk based assessment of the findings, ISO 10993-1, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-18): NeuGuide was demonstrated to be biocompatible.
- Corrosion (Anchor - cyclic potentiodynamic polarization, Applicator - Boil test, copper sulfate corrosion test, Anchor - ASTM F2129, Applicator - ASTM F1089): Both tests were passed according to predefined acceptance criteria.
- Suture testing (Anchor to suture attachment force, Suture diameter, Suture tearing force, USP 37-NF32, USP 37-NF32 , USP 37-NF32 ): Pass according to predefined acceptance criteria.
- Anchor strength and fixation forces (Anchor spurs shear force, Anchor deployment, Anchor pull-out force in porcine ligament in situ): Pass according to predefined acceptance criteria.
- Functional testing (Test entire system together for functionality): Pass according to predefined acceptance criteria.
- MRI compatibility- 3 Tesla (Magnetic field interactions, MR related heating, Artifact test, MR conditional labeling): The NeuGuide™ Anchor was demonstrated to be MR Conditional. A patient with this device can be scanned safely, immediately after placement under conditions specified in the labeling.
- Sterilization validation (ETO validation to SAL 10-6, LAL endotoxin pyrogenicity, ETO residual levels): Pass according to predefined acceptance criteria.
- Packaging validation (Sterile barrier validation at To and after 1 year shelf life): Testing supports 1 year shelf life.
- Shelf life validation (Functional validation of product after 1 year shelf life): Testing supports 1 year shelf life.
- Transportation validation (Functional testing of device after transportation): Pass according to predefined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
POP Medical Solutions Paul Dryden Regulatory Consultant 27 Habarzel St. Tel Aviv. 6971039 IL
Re: K160569 Trade/Device Name: NeuGuide Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: Class II Product Code: PBQ Dated: June 10, 2016 Received: June 13, 2016
Dear Paul Dryden,
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Benjamin R. Fisher -S
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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Indications for Use
510(k) Number (if known) K160569
Device Name NeuGuide
Indications for Use (Describe)
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for POP Medical Solutions. The logo features the letters "POP" stacked on top of each other in a stylized, blue font. Below the logo, the words "Medical Solutions" are written in a smaller, sans-serif font. Underneath that, the words "POP NeuGuide" are written in a larger, sans-serif font.
510(k) summary
| 1. | Submitter | |
|---|---|---|
| Submitted by: | Pop Medical Solutions Ltd. | |
| Habarzel St. 27, Tel Aviv 6971039, Israel | ||
| Phone: +972-3- 7684948 | ||
| Fax: +972-3- 7684941 | ||
| Official contact: | Guy Ohad, CEO | |
| Date prepared: | 10-June-2016 | |
| 2. | Device | |
| Trade name: | NeuGuide | |
| Common name: | Pelvic ligament fixation system | |
| Regulation/ | 21 CFR 884.4530 - Obstetric-gynecologic specialized manual instrument | |
| Classification name: | ||
| Product Code: | PBQ - Fixation, non-absorbable or absorbable, for pelvic use | |
| Regulatory class: | II | |
| 3. | Predicate device | |
| Predicate device: | K120831 Neomedic Anchorsure |
4. Device description
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.
| Component | Characteristics | Material |
|---|---|---|
| Anchor | Diameter 2.0 mm | |
| Length 9.0 mm | Nitinol | |
| Suture | USP 0 | |
| Diameter 0.4 mm | ||
| Length 740 mm | Polypropylene monofilament | |
| Applicator Shaft | Diameter 2.5 mm | |
| Length 284 mm | Stainless steel AISI 316L | |
| Applicator Handle | Base diameter 28mm | |
| Body diameter 6 - 14.6mm | POM-C Tecaform AH MT White | |
| Polycarbonate | ||
| Thimble | Working channel inner | |
| diameter 2.6 mm | DSM Somos WaterShedXC 11122 |
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Image /page/4/Picture/1 description: The image shows the logo for POP Medical Solutions. The logo features the letters "POP" in a stylized, blue font, with the "O"s stacked on top of the "P". Below the logo, the words "Medical Solutions" are written in a smaller, blue font. Underneath that, the words "POP NeuGuide" are written in a larger, black font.
5. Indications for use
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
6. Comparison with the predicate device
Both the subject and predicate devices are indicated for attaching sutures to ligaments of the pelvic floor.
The basic technological characteristics of the NeuGuide are the same as those of the predicate. Both are:
- Manual delivery of an anchor-suture implant via applicator handle
- . Single use, supplied sterile and pre-loaded
- Fixation in the ligament utilizing a non-absorbable suture tied to an anchor
The main technological differences between the NeuGuide and the predicate include the anchor shape (two deployable spurs on the NeuGuide vs. four stationary barbs on the predicate), anchor material (Nitinol in the NeuGuide vs. PEEK in the predicate), and the use of a thimble with the NeuGuide (no thimble is utilized with the predicate). These differences do not raise new types of safety or effectiveness questions. These differences have been evaluated in performance testing, including MRI compatibility, biocompatibility, corrosion testing, pull out force, and deployment force.
| Test | Details | Conclusions |
|---|---|---|
| Biocompatibility | Cytotoxicity, intracutaneous | |
| reactivity, sensitization, | ||
| implantation, acute systemic | ||
| toxicity, Extractable and Leachable | ||
| testing with risk based assessment of | ||
| the findings | NeuGuide was demonstrated | |
| to be biocompatible | ||
| ISO 10993-1 | ||
| ISO 10993-5 | ||
| ISO 10993-6 | ||
| ISO 10993-10 | ||
| ISO 10993-11 | ||
| ISO 10993-18 | ||
| Corrosion | Anchor - cyclic potentiodynamic | |
| polarization | ||
| Applicator - Boil test, copper sulfate | ||
| corrosion test | Both tests were passed | |
| according to predefined | ||
| acceptance criteria | ||
| Anchor - ASTM F2129 | ||
| Applicator - ASTM F1089 | ||
| Suture testing | Anchor to suture attachment force | |
| Suture diameter | ||
| Suture tearing force | Pass according to predefined | |
| acceptance criteria | ||
| USP 37-NF32 | ||
| USP 37-NF32 | ||
| USP 37-NF32 | ||
| Anchor strength and | ||
| fixation forces | Anchor spurs shear force | |
| Anchor deployment | ||
| Anchor pull-out force in porcine | ||
| ligament in situ | Pass according to predefined | |
| acceptance criteria | ||
| Functional testing | Test entire system together for | |
| functionality | Pass according to predefined | |
| acceptance criteria |
7. Performance data
The NeuGuide has undergone and successfully passed performance testing as follows:
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Image /page/5/Picture/1 description: The image contains a logo for a medical solutions company. The logo features the letters "POP" in a stylized, blue font, with the "O" appearing to be formed by a cloud-like shape. Below the logo, the words "Medical Solutions" are written in a smaller, blue font. Underneath that, the words "POP NeuGuide" are written in a larger, black font.
| MRI compatibility- 3 Tesla | Magnetic field interactions | The NeuGuide™ Anchor was |
|---|---|---|
| MR related heating | demonstrated to be MR | |
| Artifact test | Conditional. A patient with | |
| MR conditional labeling | this device can be scanned | |
| safely, immediately after | ||
| placement under conditions | ||
| specified in the labeling | ||
| Sterilization validation | ETO validation to SAL 10-6 | Pass according to predefined |
| LAL endotoxin pyrogenicity | acceptance criteria | |
| ETO residual levels | ||
| Packaging validation | Sterile barrier validation at To and | Testing supports 1 year shelf |
| after 1 year shelf life | life. | |
| Shelf life validation | Functional validation of product | Testing supports 1 year shelf |
| after 1 year shelf life | life. | |
| Transportation validation | Functional testing of device after | Pass according to predefined |
| transportation | acceptance criteria |
8. Conclusions
NeuGuide is substantially equivalent to the predicate device.